Suzetrigine

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).

• 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.

• 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.contraindicated

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 ) 2.1 Recommended 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) ].

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 ) 5.1 Increased 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) ] . 5.2 Risk 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) ].

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. 6.1 Clinical 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.

8.1 Pregnancy 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.

Metabolism

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 V 1.8 than suzetrigine by 3.7-fold.

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.

• Jan 30, 2025NDANDA219209Vertex Pharms Inc

1. 1Off Label Use17719%
2. 2Pruritus10211%
3. 3Rash747.8%
4. 4Paraesthesia707.3%
5. 5Nausea697.2%
6. 6Dizziness636.6%
7. 7Muscle Spasms505.2%
8. 8Fatigue414.3%
9. 9Drug Ineffective384.0%
10. 10Somnolence353.7%
11. 11Headache333.5%
12. 12Insomnia323.4%
13. 13Diarrhoea303.1%
14. 14Feeling Abnormal282.9%
15. 15Hypoaesthesia262.7%

The 10 most recently updated of 43 ClinicalTrials.gov registrations naming Suzetrigine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Suzetrigine in Total Hip Arthroplasty
  Recruiting · Phase 3 · Interventional · 210 enrolled · Hospital for Special Surgery, New York
  NCT07226700updated 2026-06-03
• Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty
  Not yet recruiting · Phase 4 · Interventional · 75 enrolled · Emory University
  NCT07624526updated 2026-06-03
• Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
  Not yet recruiting · Phase 4 · Interventional · 120 enrolled · University of California, Los Angeles
  NCT07600697updated 2026-06-02
• Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Participants
  Recruiting · Phase 1 · Interventional · 18 enrolled · Vertex Pharmaceuticals Incorporated
  NCT07570069updated 2026-06-02
• This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars
  Completed · Phase 2 · Interventional · 250 enrolled · Latigo Biotherapeutics
  NCT06774625updated 2026-05-22
• Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
  Recruiting · Phase 3 · Interventional · 734 enrolled · Vertex Pharmaceuticals Incorporated
  NCT07231419updated 2026-05-19
• Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
  Active not recruiting · Phase 3 · Interventional · 455 enrolled · Vertex Pharmaceuticals Incorporated
  NCT06696443updated 2026-05-18
• Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
  Recruiting · Phase 3 · Interventional · 235 enrolled · Icahn School of Medicine at Mount Sinai
  NCT07539623updated 2026-05-14
• Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants
  Recruiting · Phase 1 · Interventional · 12 enrolled · Vertex Pharmaceuticals Incorporated
  NCT07378865updated 2026-05-13
• Evaluation of Pain Treatment After Total Knee Arthroplasty
  Recruiting · Phase 4 · Interventional · 60 enrolled · Vertex Pharmaceuticals Incorporated
  NCT07538570updated 2026-05-13

Frequently asked questions

How does Suzetrigine work?

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).

What is Suzetrigine used for?

According to FDA labeling, Suzetrigine carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Suzetrigine?

Suzetrigine is classified as Sodium Channel Blocker, Cytochrome P450 3A Inducers, Cytochrome P450 3A Inhibitors, Sodium Channel Antagonists, Increased Peripheral Nervous System Organized Electrical Activity.

What are the brand names for Suzetrigine?

Suzetrigine is marketed under brand names including Journavx.

What are the contraindications for Suzetrigine?

Suzetrigine labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.