The U.S. Food and Drug Administration (FDA) accepted Teva Pharmaceuticals’ New Drug Application for ecopipam and granted it Priority Review. Ecopipam is a first-in-class investigational therapy for pediatric patients with Tourette Syndrome.
The Priority Review designation shortens the timeline for drugs that may offer significant improvements for serious conditions. If approved, ecopipam would be the first new treatment for Tourette Syndrome in over a decade. It would also mark the first novel mechanism of action for the disorder in over 50 years.
Phase 2b and Phase 3 clinical trials demonstrated that ecopipam significantly reduced tic severity and the risk of relapse. The FDA set a target action date for late in the first quarter of 2027.