17 February 2025

FDA Approves First New Class of Pain Medication in Over Two Decades

The U.S. Food and Drug Administration (FDA) has approved Journavx, the first drug in its class designed to treat moderate to severe acute pain in adults without the addictive risks associated with opioids, which have been the primary option for pain management for the past 20 years.

Developed by Boston-based Vertex Pharmaceuticals, Journavx (suzetrigine) will be available as a twice-daily oral tablet priced at $15 per dose.

The medication works by blocking pain signals before they reach the brain, specifically targeting sodium channels in the peripheral nervous system.

"Today's approval is an important public health milestone in acute pain management," said FDA spokesperson Jacqueline Corrigan-Curay, J.D., M.D. "It provides patients with another treatment option."

Journavx’s effectiveness was demonstrated in two randomized, double-blind clinical trials for acute surgical pain. Both studies showed a statistically significant reduction in pain compared to a placebo, confirming its potential as a viable alternative to traditional painkillers.

The safety of Journavx was assessed primarily through pooled data from double-blind, placebo- and active-controlled trials involving 874 surgical patients, along with additional findings from a single-arm, open-label study with 256 participants.

The most frequently reported side effects included itching, muscle spasms, elevated creatine phosphokinase levels in the blood, and skin rashes. Patients are also advised to avoid consuming grapefruit or grapefruit-containing products while taking Journavx. However, it is essential to consult a healthcare provider before starting the medication.