Vertex says FDA accepted suzetrigine new drug application

Vertex Pharmaceuticals announced that the Food and Drug Administration has accepted its new drug application submission for suzetrigine, an investigational, oral, selective NaV1.8 pain signal inhibitor to treat moderate-to-severe acute pain. “Suzetrigine has the potential to be the first new class of medicine to treat acute pain in over twenty years,” the company said in a statement. The FDA has granted suzetrigine priority review and assigned a Prescription Drug User Fee Act 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, Vertex noted.