FDA

Novel nonopioid oral analgesic wins FDA approval

January 31, 2025

Brand name: Journavx

Generic name: suzetrigine

Manufacturer: Vertex Pharmaceuticals

Approval date: January 30, 2025

FDA approved Journavx (suzetrigine) 50 mg oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. The drug reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system before pain signals reach the brain.

Efficacy

Approval was based on results from two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty (NCT05558410) and the other following bunionectomy (NCT05553366). In addition to receiving the randomized treatment, all trial participants with inadequate pain control were permitted to use ibuprofen prn for “rescue” analgesia. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared with placebo.

Safety

The most common adverse reactions in study participants who received Journavx were pruritus, muscle spasms, increased CPK levels, and rash. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx.

Sources:

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain. Food and Drug Administration. 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain

Vertex announces FDA approval of Journvax™ (suzetrigine), a first-in-class treatment for adults with moderate-to-severe acute pain. Vertex Pharmaceuticals. 2025. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class

Journavx. Package insert. Vertex Pharmaceuticals. 2025. https://pi.vrtx.com/files/uspi_suzetrigine.pdf