Journavx From Vertex Pharmaceuticals Inc

The FDA has approved suzetrigine oral tablets (Journavx; Vertex Pharmaceuticals Inc), a nonopioid oral pain signal inhibitor, for the treatment of moderate to severe acute pain in adults.^1,2 Common causes of acute pain include accident, injury, or surgery. More than 80 million individuals in the US are prescribed medication for such pain every year, and approximately half are prescribed an opioid.²

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PHARMACOLOGY AND PHARMACOKINETICS

Suzetrigine is a sodium channel blocker that inhibits the transmission of pain signals to the spinal cord and brain by selectively blocking the NaV1.8 voltage-gated sodium channel, which is expressed in peripheral sensory neurons. Suzetrigine reaches steady-state plasma concentrations after 3 days of oral administration and has an elimination half-life of 23.6 hours. It has a major active metabolite 3.7 times less potent than suzetrigine.¹

DOSAGE AND ADMINISTRATION

The recommended starting dose of suzetrigine is 100 mg orally taken on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids, such as apple juice, black coffee, tea, vegetable broth, or water, may be consumed during this time. Starting 12 hours after the initial dose, the dose of suzetrigine is 50 mg orally every 12 hours taken with or without food. The dose should be adjusted for patients with moderate hepatic impairment or taking moderate-strength CYP3A inhibitors. Starting 12 hours after the third 50-mg dose, the dosing interval should be extended to 50 mg every 24 hours. Patients with severe hepatic impairment or who are taking strong CYP3A inhibitors should not use suzetrigine. The tablets should be swallowed whole and not chewed or crushed.

Foods or drinks containing grapefruit should be avoided during treatment with suzetrigine. The medication should be used for the shortest duration possible per individual patient treatment goals. Its use for the treatment of moderate to severe acute pain for longer than 14 days has not been studied.¹

CLINICAL TRIALS

The efficacy of suzetrigine for the treatment of moderate to severe acute pain in adults was evaluated in 2 active and placebo-controlled, double-blind, randomized trials. Participants with moderate to severe acute pain were randomly assigned to receive hydrocodone bitartrate/acetaminophen, suzetrigine, or placebo for 48 hours after either a full abdominoplasty procedure (trial 1; NCT05558410) or bunionectomy (trial 2; NCT05553366). The phase 3 trials measured pain intensity with a patient-reported 11-point numeric pain rating scale, where 0 corresponded to no pain and 10 to the worst pain imaginable. Data from both trials showed that patients taking suzetrigine demonstrated a statistically significant reduction in pain compared with those taking placebo.¹

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

Patients with severe hepatic impairment should not take suzetrigine. Because patients with moderate hepatic impairment may have an increased risk of adverse reactions, the recommended dose is lower than in patients with normal hepatic function. The effectiveness and safety of suzetrigine have not been established for pediatric patients. There are no available data regarding the use of suzetrigine during pregnancy or while breastfeeding. Patients taking suzetrigine and hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use an additional nonhormonal contraceptive method or an alternative hormonal contraceptive during treatment and for 28 days after discontinuing suzetrigine.

Treatment with suzetrigine is contraindicated when it is used concomitantly with strong CYP3A inhibitors. The dose of suzetrigine should be reduced when used concomitantly with moderate-strength CYP3A inhibitors. Suzetrigine should not be used with strong or moderate CYP3A inducers. When suzetrigine is used concomitantly with sensitive CYP3A substrates or CYP3A substrates in which minimal concentration changes may affect the substrate efficacy, a dose adjustment of the substrate may be required. Initiation and discontinuation of suzetrigine may require a substrate dose adjustment. The most common adverse reactions are increased creatine phosphokinase levels, muscle spasms, pruritus, and rash.1

REFERENCES

1.Journavx. Prescribing information. Vertex Pharmaceuticals Inc; 2025. Accessed April 23, 2025. https://pi.vrtx.com/files/uspi_suzetrigine.pdf

2. Vertex announces FDA approval of Journavx (suzetrigine), a first-in-class treatment for adults with moderate-to-severe acute pain. News release. Vertex Pharmaceuticals Inc. January 30, 2025. Accessed April 23, 2025. https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class