Teva Submits NDA for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Tourette Syndrome

Teva Pharmaceutical has submitted a New Drug Application (NDA) to the FDA for ecopipam, a first-in-class dopamine D1 receptor antagonist for treating pediatric Tourette syndrome. The submission is supported by positive Phase 3 data published in JAMA Neurology, showing ecopipam significantly delayed time to relapse compared to placebo with a p-value of 0.008. If approved, ecopipam could be the first FDA-approved treatment for pediatric Tourette syndrome in over a decade.