Home › NDC Lookup › Ingredients › Suzetrigine › 85766-0243-99
JOURNAVX Suzetrigine 50 mg Tablet, Film Coated — NDC 85766-0243-99 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

JOURNAVX Suzetrigine 50 mg Tablet, Film Coated — NDC 85766-243-99 (Billing 85766-0243-99)

by Sportpharm LLC · 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of JOURNAVX Suzetrigine 50 mg Tablet, Film Coated from Sportpharm LLC, marketed since Jan 2025 and currently FDA-listed.

NDC 85766-0243-99
🏷️ FDA NDC (as labeled) 85766-243-99 billing pads the product segment with a zero
This package
Contains10 tablet, film coated in 1 blister pack Pack sizes4 compare ↓
Product page 85766-0243-01 Also comes in: 20 tablets 85766-243-20 30 tablets 85766-243-30 100 tablets 85766-243-01
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 85766-243-99 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
85766 labeler · 243 product · 99 package
Package marketed since
Jul 13, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8576624399 2
FDA record last changed
Aug 6, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85766-243-99
Product NDC 85766-243
11-digit billing NDC 85766024399
RxCUI 2704833, 2704839
UNII LOG73M21H5
Application # NDA219209
SPL Set ID d229cf71-96ec-4206-960b-d56fafc250ac
Established class (EPC) Sodium Channel Blocker
Mechanism of action Sodium Channel Antagonists; Cytochrome P450 3A Inducers
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-30
Route ORAL
Dosage form TABLET, FILM COATED
Substance SUZETRIGINE
Quick answers
  • RxCUI (RxNorm): 2704833
Why two NDCs? The FDA registers this code as 85766-243-99 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 85766-0243-99. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

📖 What it is MedlinePlus · NLM

Suzetrigine is used as a short-term treatment to relieve moderate to severe pain. Suzetrigine is in a class of medications called sodium channel blockers. It works by blocking pain signals in the body.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 tablets 30 tablets 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85766-0243-01 85766-243-01 Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2026-07-13 — Active
85766-0243-30 85766-243-30 30 TABLET, FILM COATED in 1 BOTTLE 2026-07-13 — Active
85766-0243-99 You're viewing this 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK 2026-07-13 — Active
85766-0243-20 85766-243-20 20 TABLET, FILM COATED in 1 BOTTLE 2026-07-21 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of JOURNAVX Suzetrigine 50 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Journavx 50 mg 51167-0548-25 Vertex 5 tablets — — FDA listed —
Journavx 50 mgthis 85766-0243-99 Sportpharm 10 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
First FDA approval
Jan 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2040
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 30, 2025 RLD RS ⏳ ~14.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11834441 — drug substance (U-4125)
Exclusivity NCE
2025 2027 2029 2031 2033 2035 2037 2039 2041
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 11834441 ↗ Drug substance U-4125 Dec 4, 2040
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Jan 30, 2030
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2040 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color blue
ShapeOval
ImprintVX50
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII A7ZHS2RJ34
    A cellulose-derived polymer made by chemically modifying plant fiber. It acts as a film-former and enteric coating to protect medicine from stomach acid and control where it dissolves in the digestive tract.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSportpharm LLC
Application holderVERTEX PHARMACEUTICALS INC
FDA applicationNDA219209 (NDA)
Labeler code85766
First marketedJan 2025
Product typeHuman Prescription Drug
Portfolio262 products on file

More NDCs from Sportpharm LLC labeler code 85766

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

1 INDICATIONS AND USAGE JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Swallow JOURNAVX tablets whole and do not chew or crush. ( 2.1 ) Recommended starting JOURNAVX oral dose is 100 mg. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food.

Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). ( 2.1 ) Starting 12 hours after the starting dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food.

( 2.1 ) Use JOURNAVX for the shortest duration, consistent with individual patient treatment goals. Use of JOURNAVX for the treatment of acute pain has not been studied beyond 14 days. ( 2.1 ) See the full prescribing information for the recommended dosage in patients with hepatic impairment ( 2.2 ), for JOURNAVX dosage modifications with concomitant use of CYP3A inhibitors ( 2.3 ), and recommendations regarding missed dose(s).

( 2.4 ) Avoid food or drink containing grapefruit during treatment with JOURNAVX. ( 2.3 )

2.1Recommended Dosage and Administration Instructions Swallow JOURNAVX tablets whole and do not chew or crush. The recommended starting dose of JOURNAVX is 100 mg orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food to avoid delay in onset of action [see Clinical Pharmacology (12.3) ].

Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food [see Clinical Pharmacology (12.3) ].

Avoid food or drink containing grapefruit during treatment with JOURNAVX [see Dosage and Administration (2.3) ]. Use JOURNAVX for the shortest duration, consistent with individual patient treatment goals. Use of JOURNAVX for the treatment of moderate to severe acute pain has not been studied beyond 14 days.

2.2Recommended Dosage in Patients with Hepatic Impairment The recommended dosage of JOURNAVX in patients with hepatic impairment is described in Table 1. Table 1: Recommended JOURNAVX Dosage in Patients with Hepatic Impairment Degree of Hepatic Impairment (HI) Recommended Dosage Severe HI (Child-Pugh Class C) Avoid use [see Use in Specific Populations (8.6) ]. Moderate HI (Child-Pugh Class B) Dose 1 : The recommended starting dose of JOURNAVX is 100 mg taken orally.

Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food [see Clinical Pharmacology (12.3) ]. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). Doses 2, 3, and 4 : Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours.

Take these doses with or without food [see Clinical Pharmacology (12.3) ]. Dose 5 and Subsequent Doses : Starting 12 hours after Dose 4, take 50 mg of JOURNAVX orally every 24 hours. Take these dose(s) with or without food [see Clinical Pharmacology (12.3) ].

Mild HI (Child-Pugh Class A) The recommended dosage is the same as in those with normal hepatic function [see Dosage and Administration (2.1) ].

2.3Dosage Modifications for CYP3A Inhibitors JOURNAVX is contraindicated in patients taking strong CYP3A inhibitors. When JOURNAVX is administered to patients taking moderate CYP3A inhibitors reduce the JOURNAVX dose, as described below: Dose 1 : The recommended starting dose of JOURNAVX is 100 mg orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food [see Clinical Pharmacology (12.3) ].

Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). Doses 2, 3, and 4 : Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food [see Clinical Pharmacology (12.3) ].

Dose 5 and Subsequent Doses : Starting 12 hours after Dose 4, take 50 mg of JOURNAVX orally every 24 hours. Take these dose(s) with or w… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 50 mg, blue, film-coated, oblong tablets debossed with "VX50" on one side and plain on the other. Tablets: 50 mg ( 3 )

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . Concomitant use with strong CYP3A inhibitors is contraindicated. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Moderate and Severe Hepatic Impairment : Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Use in patients with moderate hepatic impairment may increase the risk of adverse reactions. The recommended dosage is lower in patients with moderate hepatic impairment (Child-Pugh Class B) than those with normal hepatic function. ( 5.4 )

5.1Increased Risk of Adverse Reactions with Concomitant Use with Strong or Moderate CYP3A Inhibitors Strong and moderate CYP3A inhibitors increase suzetrigine and M6-SUZ (active metabolite) exposures which may cause JOURNAVX adverse reactions. Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] . Reduce the JOURNAVX dosage with moderate CYP3A inhibitors [see Dosage and Administration (2.3) ] .

5.2Risk of Drug Interactions with Certain CYP3A Substrates Suzetrigine is an inducer of CYP3A. If JOURNAVX is used concomitantly with sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, refer to the Prescribing Information for the CYP3A substrates for dosing instructions. Dosage adjustment of the concomitant CYP3A substrates may be required when initiating or discontinuing JOURNAVX [see Drug Interactions (7.2) , Clinical Pharmacology (12.3) ].

5.3Risk of Drug Interactions with Certain Hormonal Contraceptives JOURNAVX-treated patients taking concomitant hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use additional nonhormonal contraceptives (such as condoms) or use alternative contraceptives (e.g., a combined oral contraceptive containing ethinyl estradiol as the estrogen and levonorgestrel or norethindrone as the progestin, an intrauterine system) during JOURNAVX treatment and for 28 days after discontinuation of JOURNAVX [see Drug Interactions (7.2) , Clinical Pharmacology (12.3) ].

5.4Risk of Adverse Reactions in Patients with Moderate and Severe Hepatic Impairment Patients with moderate hepatic impairment have higher systemic exposures of suzetrigine and M6-SUZ (active metabolite) than those with normal hepatic function which may increase the risk of JOURNAVX related adverse reactions [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] . Avoid use of JOURNAVX in patients with severe hepatic impairment (Child-Pugh Class C). The recommended JOURNAVX dosage is lower in patients with moderate hepatic impairment (Child-Pugh Class B) than those with normal hepatic function [see Dosage and Administration (2.2) ].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (greater incidence in JOURNAVX-treated patients compared to placebo-treated patients) were pruritus, muscle spasms, increased creatine phosphokinase, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vertex Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety profile of JOURNAVX is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 adult patients with moderate to severe acute pain following full abdominoplasty (Trial 1) and bunionectomy (Trial 2) [see Clinical Studies (14) ] , with supportive safety data from one single arm trial in 256 adult patients with moderate to severe acute pain in a broad range of acute pain conditions (Trial 3).

In Trials 1 and 2, 874 patients received at least one dose of JOURNAVX. The proportion of patients in Trials 1 and 2 who discontinued study drug prematurely due to adverse events was: 0.6% in JOURNAVX-treated patients (postprocedural hematoma [0.2%], hypotension [0.2%], syncope [0.1%]), 0.6% in hydrocodone bitartrate/acetaminophen (HB/APAP)-treated patients (hypotension/orthostatic hypotension [0.2%], migraine [0.1%], intra-abdominal hematoma [0.1%], nausea [0.1%], pyrexia [0.1%]), and 0.2% in placebo-treated patients (hypotension [0.2%], tachycardia [0.2%]).

The safety profile of JOURNAVX was also evaluated by the following subgroup analyses: age (≥ 18 to < 65 years and ≥ 65 years), sex, and race. Since most patients enrolled in the clinical trials were ≥ 18 to < 65 years of age, female, and white, there was insufficient data to detect differences in safety signals between these subgroups. Table 2 displays adverse reactions that occurred more frequently in JOURNAVX-treated patients than placebo-treated patients in the pooled Trials 1 and 2.

Table 2: Adverse Reactions Reported in ≥1% of JOURNAVX-Treated Patients and Greater than Rate of Placebo in Two 48-hour Trials in Moderate to Severe Acute Pain (Trials 1 and 2, Pooled) Adverse Reactions (Preferred Term) Placebo (N = 438) n (%) JOURNAVX (N = 874) n (%) HB/APAP Patients received 5 mg/325 mg of oral hydrocodone bitartrate/acetaminophen (HB/APAP) every 6 hours. (N = 879) n (%) Pruritus 7 (1.6) 18 (2.1) 30 (3.4) Muscle spasms 2 (0.5) 11 (1.3) 6 (0.7) Increased blood creatine phosphokinase 2 (0.5) 10 (1.1) 7 (0.8) Rash 2 (0.5) 10 (1.1) 6 (0.7) Nausea and Vomiting In Trial 1, the incidence of patients who experienced either nausea or vomiting was 20% in JOURNAVX-treated patients, 33% in HB/APAP-treated patients, and 25% in placebo-treated patients.

In Trial 2, the incidence of patients who experienced either nausea or vomiting was 9% in JOURNAVX-treated patients, 16% in HB/APAP-treated patients, and 12% in placebo-treated patients. Laboratory Abnormalities Creatine Phosphokinase Elevations: In Trials 1 and 2, 2.9% of JOURNAVX-treated patients and 1.2% of placebo-treated patients had a creatine phosphokinase (CPK) level > 3 times the upper limit of normal. The incidence of increased blood CPK was 1.1% in JOURNAVX-treated patients and 0.5% in placebo-treated patients.

All reports of CPK elevations occurred in the post-surgical setting. There were no associated signs or symptoms, no serious adverse reactions, and no patients required treatment discontinuation or interruption. Decreased Estimated Glomerular Filtration Rate: In Trials 1 and 2, 2.5% of JOURNAVX-treated patients and 0.9% of placebo-treated patients had a decrease in estimated glomerular filtration rate (eGFR) of ≥ 25% but < 50%.

Follow-up eGFR data for these controlled trials was not available after treatment discontinuation. S… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Strong and Moderate CYP3A inhibitors : Concomitant use with strong CYP3A inhibitors is contraindicated. Reduce the JOURNAVX dose when used concomitantly with moderate CYP3A inhibitors. Avoid food or drink containing grapefruit.

( 2.3 , 7.1 , 12.3 ) Strong and Moderate CYP3A inducers : Avoid JOURNAVX use with strong or moderate CYP3A inducers. ( 7.1 , 12.3 ) CYP3A substrates : If JOURNAVX is used concomitantly with sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, refer to the Prescribing Information for the CYP3A substrates for dosing instructions. Dosage modification of the concomitant CYP3A substrates may be required when initiating or discontinuing JOURNAVX.

( 7.2 , 12.3 ) Hormonal contraceptives : JOURNAVX-treated patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use an additional nonhormonal contraceptive method or an alternative hormonal contraceptive during concomitant use and for 28 days after JOURNAVX discontinuation. ( 7.2 )

7.1Effect of Other Drugs on JOURNAVX Table 3 describes drug interactions where concomitant use of another drug affects the use of JOURNAVX. Table 3: Drug Interactions: Concomitant Use of Other Drugs that Affect the Use of JOURNAVX Strong and Moderate Food or drink containing grapefruit should be avoided during treatment with JOURNAVX. CYP3A Inhibitors Prevention or Management Strong CYP3A inhibitors: Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated [see Warnings and Precautions (5.1) ] .

Moderate CYP3A inhibitors: Reduce the JOURNAVX dosage [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] . Mechanism and Clinical Effect(s) Suzetrigine and M6-SUZ are CYP3A substrates. Strong and moderate CYP3A inhibitors increase suzetrigine and M6-SUZ (active metabolite of suzetrigine) exposures [see Clinical Pharmacology (12.3) ], which may cause JOURNAVX adverse reactions .

Strong and Moderate CYP3A Inducers Prevention or Management Avoid concomitant use of JOURNAVX with strong and moderate CYP3A inducers. Mechanism and Clinical Effect(s) Suzetrigine and M6-SUZ are CYP3A substrates. Concomitant use of strong or moderate CYP3A inducers results in reduced exposures of suzetrigine and M6-SUZ, which may result in reduced JOURNAVX efficacy [see Clinical Pharmacology (12.3) ] .

7.2Effect of JOURNAVX on Other Drugs CYP3A Substrates If JOURNAVX is used concomitantly with sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, refer to the Prescribing Information for the CYP3A substrates for dosing instructions. Dosage modification of the concomitant CYP3A substrates may be required when initiating or discontinuing JOURNAVX [see Warnings and Precautions (5.2) ] . Suzetrigine is an inducer of CYP3A.

Concomitant use with JOURNAVX may reduce the exposure of sensitive CYP3A substrates which may decrease the efficacy of these substrates. Discontinuation of JOURNAVX may increase the exposure of sensitive CYP3A substrates [see Warnings and Precautions (5.2) , Clinical Pharmacology (12.3) ] . Hormonal Contraceptives JOURNAVX-treated patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use additional nonhormonal contraceptives (such as condoms), or use alternative contraceptives (such as a combined oral contraceptive containing ethinyl estradiol as the estrogen and levonorgestrel or norethindrone as the progestin, or an intrauterine system) during treatment with JOURNAVX and for 28 days after discontinuation of JOURNAVX [see Warnings and Precautions (5.3) ] .

JOURNAVX did not result in clinically significant changes in the pharmacokinetics of ethinyl estradiol and levonorgestrel when used concomitantly with an oral contraceptive containing ethinyl estradiol and levonorgestrel [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on the use of JOURNAVX during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies in rats, effects on implantation and maintenance of pregnancy occurred at oral suzetrigine doses of ≥ 2.2-times the maximum recommended human dose (MRHD) when administered during early embryonic development or throughout organogenesis. In a pre- and postnatal development study, reduced mean gestation length and increased postnatal pup mortality were observed at maternal rat exposures of 1.6-times the MRHD and decreased rat pup body weights were observed during the period of birth to weaning at maternal exposures of 2.2-times the MRHD.

No malformations were observed when suzetrigine was administered orally to rats and rabbits during the period of organogenesis at doses up to 2.2- and 5.9-times, respectively, the MRHD. The clinical relevance of these findings is unclear. The background risk of major birth defects and miscarriage in patients with moderate to severe acute pain is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Suzetrigine was administered orally to pregnant rabbits during the period of organogenesis at 50, 100, and 200 mg/kg/day (approximately 1.6-, 3.1-, and 5.9-times, respectively, the steady state MRHD exposure based on AUC).

Increased post-implantation loss and lower fetal body weight were observed at 200 mg/kg/day, which is a dose that also caused maternal toxicity. No adverse embryofetal effects were observed at doses up to 100 mg/kg. Suzetrigine was administered orally to pregnant rats during the period of organogenesis at 5, 10, and 15 mg/kg/day (approximately 0.57-, 1.6-, and 2.2-times, respectively, the steady state MRHD exposure based on AUC).

Increased post-implantation loss and lower number of live fetuses were observed at 15 mg/kg/day. No adverse embryofetal effects were observed at doses up to 10 mg/kg. Placental transfer of suzetrigine was observed in pregnant rats.

In a pre- and postnatal development study, suzetrigine was administered orally to pregnant rats at doses of 5, 10, and 15 mg/kg/day (approximately 0.57-, 1.6-, and 2.2-times, respectively, the steady state MRHD exposure based on AUC) from Gestation Day 6 through Lactation Day 20. Reduced mean gestation length and increased postnatal pup mortality between birth and Postnatal Day 4 were observed at ≥ 10 mg/kg and increased incidences of fully resorbed litters, lower live newborn pups, and reductions in pup body weights were observed at 15 mg/kg.

No effects on learning and memory or sexual maturation were observed at dose up to 15 mg/kg/day. The effects on implantation, maintenance of pregnancy, reduced mean gestation length, and increased postnatal pup mortality in rats are of uncertain relevance to humans.

8.2Lactation Risk Summary There are no data on the presence of suzetrigine or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Suzetrigine is present in animal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for JOURNAVX and any potential adverse effects on the breastfed child from JOURNAVX or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Advise patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone to use an additional nonhormonal contraceptive or to use alternative contraceptives during JOURNAVX t… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on the use of JOURNAVX during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies in rats, effects on implantation and maintenance of pregnancy occurred at oral suzetrigine doses of ≥ 2.2-times the maximum recommended human dose (MRHD) when administered during early embryonic development or throughout organogenesis. In a pre- and postnatal development study, reduced mean gestation length and increased postnatal pup mortality were observed at maternal rat exposures of 1.6-times the MRHD and decreased rat pup body weights were observed during the period of birth to weaning at maternal exposures of 2.2-times the MRHD.

No malformations were observed when suzetrigine was administered orally to rats and rabbits during the period of organogenesis at doses up to 2.2- and 5.9-times, respectively, the MRHD. The clinical relevance of these findings is unclear. The background risk of major birth defects and miscarriage in patients with moderate to severe acute pain is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Suzetrigine was administered orally to pregnant rabbits during the period of organogenesis at 50, 100, and 200 mg/kg/day (approximately 1.6-, 3.1-, and 5.9-times, respectively, the steady state MRHD exposure based on AUC).

Increased post-implantation loss and lower fetal body weight were observed at 200 mg/kg/day, which is a dose that also caused maternal toxicity. No adverse embryofetal effects were observed at doses up to 100 mg/kg. Suzetrigine was administered orally to pregnant rats during the period of organogenesis at 5, 10, and 15 mg/kg/day (approximately 0.57-, 1.6-, and 2.2-times, respectively, the steady state MRHD exposure based on AUC).

Increased post-implantation loss and lower number of live fetuses were observed at 15 mg/kg/day. No adverse embryofetal effects were observed at doses up to 10 mg/kg. Placental transfer of suzetrigine was observed in pregnant rats.

In a pre- and postnatal development study, suzetrigine was administered orally to pregnant rats at doses of 5, 10, and 15 mg/kg/day (approximately 0.57-, 1.6-, and 2.2-times, respectively, the steady state MRHD exposure based on AUC) from Gestation Day 6 through Lactation Day 20. Reduced mean gestation length and increased postnatal pup mortality between birth and Postnatal Day 4 were observed at ≥ 10 mg/kg and increased incidences of fully resorbed litters, lower live newborn pups, and reductions in pup body weights were observed at 15 mg/kg.

No effects on learning and memory or sexual maturation were observed at dose up to 15 mg/kg/day. The effects on implantation, maintenance of pregnancy, reduced mean gestation length, and increased postnatal pup mortality in rats are of uncertain relevance to humans.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of JOURNAVX has not been established in pediatric patients.

🧓 Geriatric Use 96 words ▾

8.5Geriatric Use Of the total 1130 patients with moderate to severe acute pain who received JOURNAVX in the Phase 3 studies [see Clinical Studies (14) ] , 71 patients (6.3%) were 65 years of age and older. Clinical studies of JOURNAVX did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, based on population pharmacokinetic analyses in patients with ages ranging from 18 to 75 years, age does not have a clinically relevant impact on suzetrigine exposure [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 49 words ▾

10 OVERDOSAGE No specific antidote is available for overdose with JOURNAVX. Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Suzetrigine is a selective blocker of the Na V 1.8 voltage-gated sodium channel, compared to other known voltage-gated sodium channels (Na V 1.1 through 1.9). Na V 1.8 is expressed in peripheral sensory neurons including dorsal root ganglion neurons, where its role is to transmit pain signals (action potentials). By selectively inhibiting Na V 1.8 channels, suzetrigine inhibits transmission of pain signals to the spinal cord and brain.

M6-SUZ, a major active metabolite, is a less potent inhibitor of Na V 1.8 than suzetrigine by 3.7-fold.

12.2Pharmacodynamics Cardiac Electrophysiology At 2 times the exposure of the maximum recommended JOURNAVX dose, clinically significant QTc prolongation was not observed.

12.3Pharmacokinetics The pharmacokinetic parameters for suzetrigine and its major active metabolite, M6-SUZ, are shown in Table 4. Table 4: Pharmacokinetic Parameters of Suzetrigine and M6-SUZ Suzetrigine M6-SUZ (Active Metabolite) Based on an in vitro electrophysiology assay in human dorsal root ganglion neurons, M6-SUZ is a less potent inhibitor of Na V1.8 than suzetrigine by 3.7-fold. AUC: area under the concentration versus time curve; CV: coefficient of variation; C max : maximum observed concentration; T max : time of maximum concentration; NA: not applicable General Information Steady State AUC 0-24h (CV%), µg*h/mL 11.5 (25.6%) 34.7 (25.6%) Steady State C max (CV%), µg/mL 0.62 (27.7%) 1.5 (24.5%) Time to 90% Steady State, days 3 5 Mean (CV%) Accumulation Ratio Based on simulations of a dose of 50 mg every 12 hours (q12h).

3.4(30.2%) 4.5 (30.6%) Absorption Median T max (range), hours 3.0 hours (1.50, 5.03) 10.0 hours (4.0, 48.1) Distribution Suzetrigine and M6-SUZ do not partition preferentially into human red blood cells. Mean (CV%) Apparent Volume of Distribution, L 495 (25.0%) NA Protein Binding 99% 96% Elimination Mean (CV%) Effective Half-Life, hours 23.6 (36.2%) 33.0 (34.9%) Steady State Mean (CV%) Apparent Oral Clearance, L/hours 13.9 (37.5%) NA Metabolism Primary Pathway CYP3A CYP3A Excretion Primary Pathway Feces: 49.9% (9.1% SUZ and rest as metabolites) Urine: 44.0% (primarily as metabolites) Effect of Food Administration of 100 mg of JOURNAVX (the first dose) with a high-fat meal (800 to 1000 calories, 50% derived from fat), a moderate-fat meal (600 calories, 30% derived from fat), and a low-fat meal (up to 500 calories with no more than 25% derived from fat) resulted in decreased initial concentrations of suzetrigine and M6-SUZ in comparison to a fasted state.

The median T max of suzetrigine and M6-SUZ in the fasted state was 3 hours and 8 to 10 hours, respectively. When administered in the fed state (high-fat meal or moderate-fat meal) the median T max of suzetrigine was delayed to 5 hours and the median T max of M6-SUZ was delayed to 24 hours. The C max and AUC of suzetrigine and M6-SUZ were not affected by any of the meal conditions, including a high-fat meal consumed one hour after JOURNAVX administration.

Administration of the second JOURNAVX dose of 50 mg with or without regard to meals is predicted to not affect the systemic exposures of suzetrigine and M6-SUZ. Specific Populations No clinically significant differences in pharmacokinetics of suzetrigine and M6-SUZ were observed based on age (18-75 years), sex, body weight (44-126 kg), race, and renal impairment (eGFR ≥ 15 mL/min by CKD-EPI equation with adjustment for the body surface area). The effect of renal impairment with eGFR < 15 mL/min on suzetrigine and M6-SUZ pharmacokinetics is unknown.

Patients with Hepatic Impairment In patients with mild hepatic impairment (Child-Pugh Class A), no clinically significant differences in pharmacokinetics of suzetrigine and M6-SUZ were observed. In patients with moderate hepatic impairment (Child-Pugh Class B), at steady state, suzetrigine AUC 0-12h increased by 1.5-fold (90% CI: 1.1-2.1) and C max increased by 1.3-fold (90% CI: 1.0-1.7) and M6-SUZ AUC 0-1… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 90 words ▾

12.1Mechanism of Action Suzetrigine is a selective blocker of the Na V 1.8 voltage-gated sodium channel, compared to other known voltage-gated sodium channels (Na V 1.1 through 1.9). Na V 1.8 is expressed in peripheral sensory neurons including dorsal root ganglion neurons, where its role is to transmit pain signals (action potentials). By selectively inhibiting Na V 1.8 channels, suzetrigine inhibits transmission of pain signals to the spinal cord and brain.

M6-SUZ, a major active metabolite, is a less potent inhibitor of Na V 1.8 than suzetrigine by 3.7-fold.

📦 How Supplied / Storage and Handling 105 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING JOURNAVX (suzetrigine) tablets are supplied as blue, film-coated, oblong tablets containing 50 mg of suzetrigine. Each tablet is debossed with the characters "VX50" on one side and plain on the other, and is packaged as follows: 20-count bottle NDC 85766-243-20 (repackaged from NDC 51167-548-XX) 30-count bottle NDC 85766-243-30 (relabeled from NDC 51167-548-30) 100-count bottle NDC 85766-243-01 (relabeled from NDC 51167-548-31) 100-count Hospital Unit Dose Carton (10 blister cards, each containing 10 tablets) NDC 85766-243-99 (relabeled from NDC 51167-548-34) Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].

📦 Storage and Handling 22 words ▾

Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].

📋 Description 122 words ▾

11 DESCRIPTION The active ingredient in JOURNAVX (suzetrigine) tablets is suzetrigine, a sodium channel blocker, which has the following chemical name: 4-[(2 R ,3 S ,4 S ,5 R )-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)oxolane-2-amido]pyridine-2-carboxamide. Its molecular formula is C 21 H 20 F 5 N 3 O 4 . Suzetrigine's molecular weight is 473.39 g/mol.

Suzetrigine has the following structural formula: Suzetrigine is a white to off-white solid and is practically insoluble in water. JOURNAVX is available as a blue, film-coated tablet for oral administration containing 50 mg of suzetrigine and the following inactive ingredients: croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, and microcrystalline cellulose. The tablet film coat contains FD&C Blue #2 aluminum lake, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.

Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Drug Interactions Ask patients to tell you all the medications they are taking, including any herbal supplements or vitamins [see Drug Interactions (7) ] . Food or drink containing grapefruit should be avoided [see Dosage and Administration (2.3) , Drug Interactions (7.1) ] .

When used concomitantly with hormonal contraceptives containing a progestin other than levonorgestrel or norethindrone, advise patients to use an additional nonhormonal contraceptive (such as condoms) or use alternative contraceptives during JOURNAVX treatment and for 28 days after discontinuation of JOURNAVX [see Drug Interactions (7.2) ]. Females of Reproductive Potential Advise females of reproductive potential that JOURNAVX may reversibly impact the likelihood to become pregnant while on treatment. Patients using contraceptives should continue to use contraceptives [see Use in Specific Populations (8.3) ] .

Use in Patients with Hepatic Impairment Inquire and/or assess whether patients have hepatic impairment. Administration Instructions Advise patients to take the starting dose of JOURNAVX on an empty stomach at least 1 hour before or 2 hours after food to avoid delay in onset of action. Clear liquids may be consumed (such as water, apple juice, vegetable broth, tea, or black coffee) during this time.

Avoid food or drink containing grapefruit during treatment with JOURNAVX [see Dosage and Administration (2.2 , 2.3) ] . Subsequent doses of JOURNAVX can be taken with or without food. Patients should be instructed to swallow JOURNAVX tablets whole (do not chew or crush).

Inform patients about what to do in the event they miss a dose of JOURNAVX [see Dosage and Administration (2.4) ].

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic parameters for suzetrigine and its major active metabolite, M6-SUZ, are shown in Table 4. Table 4: Pharmacokinetic Parameters of Suzetrigine and M6-SUZ Suzetrigine M6-SUZ (Active Metabolite) Based on an in vitro electrophysiology assay in human dorsal root ganglion neurons, M6-SUZ is a less potent inhibitor of Na V1.8 than suzetrigine by 3.7-fold. AUC: area under the concentration versus time curve; CV: coefficient of variation; C max : maximum observed concentration; T max : time of maximum concentration; NA: not applicable General Information Steady State AUC 0-24h (CV%), µg*h/mL 11.5 (25.6%) 34.7 (25.6%) Steady State C max (CV%), µg/mL 0.62 (27.7%) 1.5 (24.5%) Time to 90% Steady State, days 3 5 Mean (CV%) Accumulation Ratio Based on simulations of a dose of 50 mg every 12 hours (q12h).

3.4(30.2%) 4.5 (30.6%) Absorption Median T max (range), hours 3.0 hours (1.50, 5.03) 10.0 hours (4.0, 48.1) Distribution Suzetrigine and M6-SUZ do not partition preferentially into human red blood cells. Mean (CV%) Apparent Volume of Distribution, L 495 (25.0%) NA Protein Binding 99% 96% Elimination Mean (CV%) Effective Half-Life, hours 23.6 (36.2%) 33.0 (34.9%) Steady State Mean (CV%) Apparent Oral Clearance, L/hours 13.9 (37.5%) NA Metabolism Primary Pathway CYP3A CYP3A Excretion Primary Pathway Feces: 49.9% (9.1% SUZ and rest as metabolites) Urine: 44.0% (primarily as metabolites) Effect of Food Administration of 100 mg of JOURNAVX (the first dose) with a high-fat meal (800 to 1000 calories, 50% derived from fat), a moderate-fat meal (600 calories, 30% derived from fat), and a low-fat meal (up to 500 calories with no more than 25% derived from fat) resulted in decreased initial concentrations of suzetrigine and M6-SUZ in comparison to a fasted state.

The median T max of suzetrigine and M6-SUZ in the fasted state was 3 hours and 8 to 10 hours, respectively. When administered in the fed state (high-fat meal or moderate-fat meal) the median T max of suzetrigine was delayed to 5 hours and the median T max of M6-SUZ was delayed to 24 hours. The C max and AUC of suzetrigine and M6-SUZ were not affected by any of the meal conditions, including a high-fat meal consumed one hour after JOURNAVX administration.

Administration of the second JOURNAVX dose of 50 mg with or without regard to meals is predicted to not affect the systemic exposures of suzetrigine and M6-SUZ. Specific Populations No clinically significant differences in pharmacokinetics of suzetrigine and M6-SUZ were observed based on age (18-75 years), sex, body weight (44-126 kg), race, and renal impairment (eGFR ≥ 15 mL/min by CKD-EPI equation with adjustment for the body surface area). The effect of renal impairment with eGFR < 15 mL/min on suzetrigine and M6-SUZ pharmacokinetics is unknown.

Patients with Hepatic Impairment In patients with mild hepatic impairment (Child-Pugh Class A), no clinically significant differences in pharmacokinetics of suzetrigine and M6-SUZ were observed. In patients with moderate hepatic impairment (Child-Pugh Class B), at steady state, suzetrigine AUC 0-12h increased by 1.5-fold (90% CI: 1.1-2.1) and C max increased by 1.3-fold (90% CI: 1.0-1.7) and M6-SUZ AUC 0-12h and C max both increased by 1.2-fold (AUC 90% CI: 0.83-1.6; C max 90% CI: 0.84-1.6). The effect of severe hepatic impairment (Child-Pugh Class C) on suzetrigine and M6-SUZ pharmacokinetics is unknown.

Drug Interaction Studies Clinical Studies and Model-Informed Approaches Strong CYP3A Inhibitors: Concomitant administration of itraconazole (a strong CYP3A inhibitor) with a single dose of JOURNAVX increased the geometric mean (90% CI) AUC 0-inf of suzetrigine and M6-SUZ by 4.8-fold (4.3-5.4) and 4.4-fold (3.6-5.4), respectively, while the geometric mean (90% CI) C max of suzetrigine increased by 1.5-fold (1.3-1.6) and C max of M6-SUZ decreased by 32% (24-39%) [see Drug Interactions (7.1) ] . Moderate CYP3A Inhibitors: Concomitant administration of flucona… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 22 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology At 2 times the exposure of the maximum recommended JOURNAVX dose, clinically significant QTc prolongation was not observed.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Overview of Clinical Studies The efficacy of JOURNAVX in the treatment of moderate to severe acute pain in adults was established in two randomized, double-blind, placebo and active-controlled trials of acute pain, one following full abdominoplasty (Trial 1) [see Clinical Studies (14.2) ] and the other following bunionectomy (Trial 2) [see Clinical Studies (14.3) ] . In each trial, pain intensity was measured using a patient-reported 11-point numeric pain rating scale (NPRS), ranging from 0 to 10, where zero corresponds to no pain and 10 corresponds to the worst pain imaginable.

Patients were eligible for study participation if they had moderate to severe pain on the verbal categorical rating system (VRS) and a pain score of ≥ 4 on the NPRS, within 4 hours of the abdominoplasty completion (Trial 1) or during the 9-hour period after discontinuation of regional anesthesia following bunionectomy (Trial 2). Once eligible, patients were randomized to receive oral JOURNAVX, placebo, or hydrocodone bitartrate/acetaminophen (HB/APAP) for a duration of 48 hours. For the JOURNAVX treatment regimen, patients received an initial loading dose of 100 mg JOURNAVX, followed by 50 mg every 12 hours.

For the HB/APAP-control regimen, patients received 5 mg/325 mg every 6 hours. For both studies, 400 mg of ibuprofen every 6 hours, as needed for pain relief, was permitted as a rescue medication.

14.2Moderate to Severe Acute Pain Following Full Abdominoplasty Trial 1 [NCT05558410] evaluated the efficacy of JOURNAVX over 48 hours in 1,118 adult patients with moderate to severe acute pain following a full abdominoplasty procedure (JOURNAVX n = 447, placebo n = 223, and hydrocodone bitartrate/acetaminophen (HB/APAP) n = 448). The majority of patients were female (98%), and the mean age was 42 years (range: 18 to 69). The study population consisted of 70% White participants, 27% Black or African American participants, 1% Asian participants, 0.8% Native Hawaiian or other Pacific Islander participants, 0.5% American Indian or Alaska Native participants, and 0.9% Other or Multiracial participants, among which 34% identified as Hispanic or Latino.

The mean pain score at baseline was 7.4 (range: 4 to 10). All baseline characteristics, including NPRS, VRS, and BMI were generally balanced across treatment arms. In Trial 1, 89% of patients in the JOURNAVX group completed the treatment period (compared to 75% of patients in the placebo group and 85% of patients in the HB/APAP group), and 9% of patients in the JOURNAVX group discontinued due to lack of efficacy (compared to 22% of patients in the placebo group and 13% of patients in the HB/APAP group).

Efficacy was evaluated by the time-weighted sum of the pain intensity difference from 0 to 48 hours (SPID48) in the JOURNAVX group compared to the placebo group and then to the HB/APAP group. Treatment with JOURNAVX demonstrated statistically significant superior reduction in pain compared to treatment with placebo (see Table 5 ). In an exploratory analysis, the time-weighted sum of the pain intensity difference from 0 to 24 hours (SPID24) reported using the least square mean was 48.0 for the JOURNAVX group and 24.2 for the placebo group.

The mean pain intensities over time are depicted for the JOURNAVX, placebo, and HB/APAP groups in Figure 1. Table 5: SPID48 Results in Adults with Moderate to Severe Acute Pain Following Full Abdominoplasty (Trial 1) Efficacy Measure JOURNAVX N = 447 Placebo N = 223 HB/APAP HB/APAP = hydrocodone bitartrate/acetaminophen N = 448 LS: Least Squares; CI: Confidence Interval LS mean A larger value of LS mean indicates better efficacy measured by SPID48. 118.4 70.1 111.8 LS Mean Difference vs placebo (95% CI) P value 48.4 (33.6, 63.1) < 0.0001 - - LS Mean Difference vs HB/APAP (95% CI) 6.6 (-5.4, 18.7) - - Figure 1: Mean Pain Intensity Over Time in Adults with Moderate to Severe Acute Pain Following Full Abdominoplasty (Trial 1) Note: Pre-rescue pain scores we… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies have not been completed to evaluate the carcinogenic potential of suzetrigine. Mutagenesis Suzetrigine was not mutagenic in the bacterial reverse mutation assay (Ames test), or clastogenic in the in vitro micronucleus assay with a human TK6 lymphoblastoid cell line, or in the in vivo rat bone marrow micronucleus assay. Impairment of Fertility In a female fertility study, female rats were treated orally with suzetrigine at 5, 10, and 15 mg/kg/day for a minimum of 14 days prior to mating, throughout mating, and through Gestation Day 7.

These doses are approximately 0.57, 1.6, and 2.2-times the steady state MRHD exposure based on AUC. Increased pre-implantation loss was observed at 15 mg/kg (approximately 2.2-times the MRHD based on AUC). The finding in rats may be explained by the effect of suzetrigine on the rat progesterone receptor, which was more sensitive to suzetrigine than the human progesterone receptor based on in vitro studies.

Following 4-week withdrawal of treatment, there were no effects on female fertility and early embryonic development. The finding in the rat study is of uncertain relevance to humans. In a male fertility study, male rats were treated orally with suzetrigine at 200, 600, and 1000 mg/kg/day for a minimum of 28 days prior to mating and through mating.

These doses are 3.6, 9.7, and 13.8-times the steady state MRHD exposure based on AUC, respectively. Suzetrigine had no effects on sperm parameters (motility, concentration, or morphology), reproductive performance or uterine parameters (number of implants, viable implants, pre-implantation loss, early resorptions, and post-implantation loss) at any dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies have not been completed to evaluate the carcinogenic potential of suzetrigine. Mutagenesis Suzetrigine was not mutagenic in the bacterial reverse mutation assay (Ames test), or clastogenic in the in vitro micronucleus assay with a human TK6 lymphoblastoid cell line, or in the in vivo rat bone marrow micronucleus assay. Impairment of Fertility In a female fertility study, female rats were treated orally with suzetrigine at 5, 10, and 15 mg/kg/day for a minimum of 14 days prior to mating, throughout mating, and through Gestation Day 7.

These doses are approximately 0.57, 1.6, and 2.2-times the steady state MRHD exposure based on AUC. Increased pre-implantation loss was observed at 15 mg/kg (approximately 2.2-times the MRHD based on AUC). The finding in rats may be explained by the effect of suzetrigine on the rat progesterone receptor, which was more sensitive to suzetrigine than the human progesterone receptor based on in vitro studies.

Following 4-week withdrawal of treatment, there were no effects on female fertility and early embryonic development. The finding in the rat study is of uncertain relevance to humans. In a male fertility study, male rats were treated orally with suzetrigine at 200, 600, and 1000 mg/kg/day for a minimum of 28 days prior to mating and through mating.

These doses are 3.6, 9.7, and 13.8-times the steady state MRHD exposure based on AUC, respectively. Suzetrigine had no effects on sperm parameters (motility, concentration, or morphology), reproductive performance or uterine parameters (number of implants, viable implants, pre-implantation loss, early resorptions, and post-implantation loss) at any dose.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION JOURNAVX (jor na vix) (suzetrigine) tablets, for oral use This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 01/2026 What is JOURNAVX?

JOURNAVX is a prescription medicine used to treat adults with moderate to severe short-term (acute) pain, including postoperative pain. It is not known if JOURNAVX is safe and effective in children. Do not take JOURNAVX if you take certain medicines that are strong inhibitors of an enzyme called CYP3A.

Ask your healthcare provider if you are not sure. Before taking JOURNAVX, tell your healthcare provider about all of your medical conditions, including if you: have liver problems. People with liver problems may have an increased risk of getting side effects from taking JOURNAVX. are pregnant or plan to become pregnant.

It is not known if JOURNAVX will harm your unborn baby. You and your healthcare provider should decide if you will take JOURNAVX while you are pregnant. are breastfeeding or planning to breastfeed. It is not known if JOURNAVX passes into your breast milk.

You and your healthcare provider should decide if you will take JOURNAVX while you are breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking JOURNAVX with certain other medicines may affect the way JOURNAVX and the other medicines work and may increase your risk of side effects.

See " Do not take JOURNAVX ". Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Especially tell your healthcare provider if you take: hormonal birth control (contraceptives) containing progestins other than levonorgestrel or norethindrone.

If you take one of these contraceptives (progestins other than levonorgestrel or norethindrone), they may not work as well during treatment with JOURNAVX. You should also use nonhormonal contraceptives such as condoms or use other forms of hormonal birth control during treatment with JOURNAVX and for 28 days after you stop taking JOURNAVX. medicines that are substrates of the CYP3A enzyme since they may become less effective during treatment with JOURNAVX. Your healthcare provider may need to adjust the dose of your medicine when starting or stopping JOURNAVX.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take JOURNAVX?

Take JOURNAVX by mouth exactly as your healthcare provider tells you to take it. Swallow JOURNAVX tablets whole. Do not chew or crush the tablets.

For your first dose of JOURNAVX: Take 2 JOURNAVX tablets on an empty stomach. Take your first dose of JOURNAVX at least 1 hour before or 2 hours after food. During this time, you may drink clear liquids, such as water, apple juice, vegetable broth, tea, or black coffee.

After your first dose of JOURNAVX: Take 1 JOURNAVX tablet 12 hours later, with or without food. Continue to take 1 JOURNAVX tablet every 12 hours as directed by your healthcare provider. Take JOURNAVX for the shortest time needed.

If you have liver problems or take certain other medicines , your dosing schedule may be different. If you miss a dose of JOURNAVX and do not have liver problems or take certain other medicines: Take the missed dose as soon as possible, then take your next scheduled dose at your recommended time. If you miss 2 or more doses of JOURNAVX, take 2 JOURNAVX tablets, then take your next scheduled dose at your recommended time.

If you miss a dose of JOURNAVX and you have liver problems or are taking moderate inhibitors of an enzyme called CYP3A: Take the missed dose as soon as possible. If you took the missed dose and your next scheduled dose is within 6 hours, skip that dose and take your next scheduled dose at your recommended time. If you are not sure about your dosing, ask your healthcare provider or pharmacist.

If you take too much JOURNAVX, call your heal… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 7 words ▾

PRINCIPAL DISPLAY PANEL - 50 mg 50

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Journavx — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Journavx. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$17.21M
Claims incl. refills
32K
Beneficiaries
24.8K
Spend / beneficiary
$693.67
Spend / claim
$538.26
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for JOURNAVX (this brand).

Top reported reactions

Pruritus142
Rash114
Nausea89
Paraesthesia85
Dizziness78
Muscle Spasms60
Headache49

Age at onset

Adolescent1
Adult55
Elderly35

Reporter sex

1,274 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization67
Disabling10
Life-threatening8
Death7
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 668 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sportpharm LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 20 tablets (85766-0243-20), 30 tablets (85766-0243-30), 100 tablets (85766-0243-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sportpharm LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 85766-0242-15 · Sportpharm 85766-0244-15 · Sportpharm →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.