Vertex Pharmaceuticals announced it will present pivotal Phase 3 data on suzetrigine, an investigational oral NaV1.8 pain signal inhibitor, at the American Society of Anesthesiologists (ASA) annual meeting from October 18-22, 2024. This marks the first public presentation of these Phase 3 results to the medical community.
The Phase 3 program included two randomized, double-blind, placebo-controlled trials following abdominoplasty and bunionectomy surgeries, along with a single-arm safety and effectiveness study. Results from all three studies demonstrated compelling and consistent efficacy and safety across multiple acute pain conditions.
Suzetrigine has been granted FDA Fast Track and Breakthrough Therapy designations for moderate-to-severe acute pain. The Prescription Drug User Fee Act (PDUFA) target action date for this indication is January 30, 2025, positioning it as a potential first non-opioid acute pain treatment in over two decades.
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