FDA accepts Vertex’ suzetrigine NDA for priority review

The US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submission for suzetrigine (VX-548), an investigational, oral, selective NaV1.8 pain signal inhibitor to treat moderate-to-severe acute pain.

Vertex Pharmaceuticals (Nasdaq: VRTX), the drug’s developed, noted that suzetrigine has the potential to be the first new class of medicine to treat acute pain in over twenty years. Analysts have previously said it could be a blockbuster if it reaches the market, but non-opioid pain drugs have a long history of failures in clinical trials.

The FDA has granted suzetrigine priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025. Suzetrigine has already been granted FDA Fast Track and Breakthrough Therapy designations for the treatment of moderate-to-severe acute pain.