Teva (TEVA) Files FDA NDA for Pediatric Tourette Syndrome Drug Ecopipam

Teva Pharmaceutical Industries (TEVA) announced filing a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Ecopipam, targeting pediatric Tourette Syndrome. This move positions the company for potential market expansion in neurological disorders. Ecopipam is a first-in-class, selective dopamine-1 (D1) receptor antagonist. The NDA submission is supported by data from the Phase 2b/3 D1AMOND study, which demonstrated Ecopipam significantly reduced motor and phonic tics in pediatric patients compared to placebo, meeting its primary endpoint. The drug was also generally well-tolerated. Tourette Syndrome affects approximately 1 in 160 children aged 5-17 in the U.S., highlighting the need for new treatment options.