Suzetrigine

Suzetrigine is indicated for the treatment of moderate to severe acute pain in adults.^[1][2] It was primarily studied in people with postoperative pain, including due to abdominoplasty and bunionectomy.^[1] However, a small minority of patients received suzetrigine for non-surgical pain, including arthralgias, limb pain, and sprains and strains.^[1] Treatment of acute pain using suzetrigine has not been studied beyond 14 days of use.^[1]

In clinical studies conducted through 2024, suzetrigine reduced pain typically from 7 to 4 on the standard numeric scale used to rate pain.^[9][10] The efficacy of suzetrigine was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy.^[2] Both trials found that suzetrigine reduced pain more effectively than placebo.^[2]

However, in clinical studies, no superiority over hydrocodone and paracetamol (acetaminophen) in terms of pain reduction was shown over 48 hours.^[11] Medical professionals have noted its efficacy may be inferior to high-dose opioid analgesics.^[12] There are no studies comparing suzetrigine with high-dose opioids. Suzetrigine exhibits CYP3A4-mediated drug interactions and there is limited long-term data regarding its use.^[13] Moreover, usage has not been studied in those younger than 18 or older than 80 years of age and its cost-effectiveness is disputed.^[7][14]

Suzetrigine is dispensed as 50 milligram oral tablets that are to be swallowed whole and not crushed or chewed.^[1][2] To avoid a delay of onset, it is recommended to begin taking a starting dose of 100 mg on an empty stomach.^[6] Following the initial dose, 50 mg is to be taken every 12 hours for the shortest possible duration.^[1] For those with moderate hepatic impairment, 50 mg doses are to be taken 24 hours apart following the fifth dose.^[1]

Concomitant use of suzetrigine with strong CYP3A4 inhibitors is contraindicated.^[1][2] When taken with moderate CYP3A inhibitors, dose adjustments are required.^[5] While taking suzetrigine, and for 28 days after use has ended, those taking hormonal contraceptives with progesterone's other than levonorgestrel and norethindrone should use additional or an alternative non-hormonal contraceptive.^[8]

Individuals with severe hepatic impairment (Child-Pugh Class C) should not take suzetrigine.^[1][8]

The most common adverse effects of suzetrigine may include itching, rash, muscle spasms, and increased levels of creatine kinase.^[2] Mild side effects may include nausea, vomiting, constipation, headache, and dizziness.^[9][10] In preliminary research, suzetrigine had no serious neurological, behavioral, addictive or cardiovascular effects.^[3]

As of 2024,^[update] long-term safety in broader contexts including multimodal analgesia, pregnancy and breastfeeding women remain undetermined.^[10]

Consuming grapefruit while using suzetrigine may cause adverse grapefruit–drug interactions.^[1][2]

Vertex Pharmaceuticals announced in January 2024 that suzetrigine had successfully met several endpoints in its Phase III clinical trials.^[7] The company announced in July 2024 that the FDA had accepted a New Drug Application for suzetrigine.^[15] Due to its novel mechanism, the FDA granted priority review, fast track, and breakthrough therapy designations to the application for suzetrigine.^[2][15] In January 2025, the FDA granted approval of Journavx to Vertex Pharmaceuticals, making it the first non-opioid pain medication to be approved by the FDA in two decades.^[2][16]

As of November 2025, Phase IV post-marketing clinical trials are underway to assess the effectiveness and safety of Suzetrigine as a part of multimodal therapy for the treatment of acute post-operative pain^[17].

The manufacturer engaged in lobbying activity promoting non-opioid pain treatment and supporting the NO PAIN Act (Non-Opioids Prevent Addiction In the Nation Act).^[18]