The U.S. Food and Drug Administration has approved suzetrigine (formerly VX-548), highlighting its approval as a new option for acute pain management. Developed by Vertex Pharmaceuticals, the selective NaV1.8 inhibitor is the first agent to to be approved in a new class of non-opioid analgesics, offering an alternative to opioid-based pain management.

“A new non-opioid 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,” said Jacqueline Corrigan-Curay, JD, MD, Acting Director of the FDA Center for Drug Evaluation and Research.

Clinical Trial Results

The FDA decision follows positive data from Vertex’s phase III program, which evaluated suzetrigine in patients with moderate-to-severe acute pain following surgery. In two randomized, double-blind, placebo-controlled trials, suzetrigine demonstrated statistically significant pain reduction compared to placebo, though it did not show superiority over treatment with hydrocodone bitartrate/acetaminophen.

• Post-abdominoplasty trial: Suzetrigine achieved a significant improvement in pain relief over 48 hours (SPID48), with a least squares mean difference of 48.4 (95% confidence interval [CI] = 33.6–63.1; P < .0001) versus placebo.

• Post-bunionectomy trial: Suzetrigine showed similar efficacy, with a least squares mean difference in SPID48 of 29.3 (95% CI = 14.0, 44.6; P = .0002), versus placebo.

• Safety and efficacy study: A single-arm trial involving 256 patients confirmed the drug’s tolerability, with 83.2% of patients rating suzetrigine as good, very good, or excellent for pain control.

Suzetrigine’s approval comes amid a growing demand for non-opioid pain management strategies, driven by regulatory efforts to reduce opioid prescriptions and updated clinical guidelines emphasizing alternative pain management approaches. By selectively inhibiting the NaV1.8 sodium channel, the drug targets peripheral pain pathways while avoiding the risks of opioid dependency. Across trials, adverse events were mostly mild to moderate, with nausea, headache, and dizziness being the most commonly reported side effects.

“As a physician treating patients suffering from pain for many years, I know firsthand the critical need for new, efficacious, and safe treatment options,” said Jessica Oswald, MD, MPH, Associate Physician in Emergency Medicine and Pain Medicine at the University of California San Diego, and Vertex Acute Pain Steering Committee Member, in a company press release. “The phase III safety and efficacy across the three studies are impressive and demonstrate suzetrigine’s potential to change the paradigm of pain management. I look forward to the potential of having a new class of acute pain medicine—the first in more than 2 decades—to use as an alternative to opioids to help the millions of people impacted by acute pain.”

With this approval, suzetrigine may reshape the acute pain treatment landscape, offering a novel approach for postsurgical and injury-related pain. Vertex plans to launch the drug later this year.