FDA approves new non-opioid analgesic

Editor's Note

The FDA has approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for the treatment of moderate to severe acute pain in adults. According to the agency’s January 30 announcement, the drug targets sodium channels in the peripheral nervous system to block pain signals before they reach the brain, representing a new approach to pain management.

Journavx was evaluated in two randomized, double-blind trials involving patients who underwent abdominoplasty or bunionectomy. Both studies showed statistically significant pain reduction compared to placebo. Patients in the trials could use ibuprofen as needed for additional pain relief. The drug’s safety profile was based on data from 874 trial participants and an additional open-label study of 256 patients with various acute pain conditions. Reported side effects included itching, muscle spasms, elevated creatine phosphokinase levels, and rash. Journavx is contraindicated for use with strong CYP3A inhibitors, and patients should avoid grapefruit products.

The FDA’s approval aligns with its Overdose Prevention Framework, which promotes non-opioid pain treatments to reduce opioid-related risks. Journavx received Breakthrough Therapy, Fast Track, and Priority Review designations to expedite its development and review. Vertex Pharmaceuticals Incorporated holds the drug’s approval.