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February 1, 2025 — In a significant advancement for pain management, the US Food and Drug Administration (FDA) has granted approval for suzetrigine 50 mg tablets (Journavx, Vertex Pharmaceuticals), marking the introduction of a first-in-class nonopioid analgesic for adults experiencing moderate-to-severe acute pain.
Suzetrigine operates by selectively inhibiting the NaV1.8 pain-signaling pathway in the peripheral nervous system, a validated target for managing peripheral pain. Unlike opioid-based pain relievers, which act on the central nervous system, suzetrigine blocks pain signals only in the periphery, providing effective relief while avoiding the addictive potential associated with opioid medications.
A Breakthrough in Nonopioid Pain Management
The FDA recognized the therapeutic potential of suzetrigine by granting it priority review, fast-track, and breakthrough therapy designations. The drug is available in 50-mg tablets and is approved for administration twice daily.
Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, emphasized the significance of this approval. “A new nonopioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” she said.
Clinical Trials and Efficacy
Suzetrigine’s approval is based on results from two phase 3 randomized, double-blind, placebo-controlled trials. One trial involved 303 adults undergoing abdominoplasty, while the second included 274 adults recovering from bunionectomy. In both studies, ibuprofen was permitted as a rescue pain medication.
Findings from the trials demonstrated a rapid and statistically significant reduction in pain for patients taking suzetrigine compared with those receiving a placebo. The drug was generally well tolerated, with the most commonly reported adverse effects being itching, muscle spasms, increased creatine phosphokinase levels, and rash.
Usage Guidelines and Pricing
Patients prescribed suzetrigine should avoid concurrent use with strong CYP3A inhibitors and refrain from consuming food or beverages containing grapefruit, as these may interfere with drug metabolism. Full prescribing information is available online.
The wholesale acquisition cost for suzetrigine in the United States is set at $15.50 per 50-mg tablet, according to Vertex Pharmaceuticals.
Disclaimer:
This article is for informational purposes only and does not constitute medical advice. Patients should consult their healthcare providers to determine whether suzetrigine is an appropriate treatment option for their condition. The FDA’s approval does not guarantee effectiveness for all individuals, and potential risks and side effects should be carefully considered.
