• NDA submission supported by positive Phase 3 data recently published in JAMA Neurology.
• Ecopipam is a first-in-class selective dopamine D1 receptor antagonist with a novel mechanism of action and has received FDA Orphan Drug and Fast Track designations
• Ecopipam could be the first FDA-approved treatment option for pediatric Tourette syndrome in more than a decade, if approved.

 Teva Pharmaceutical Industries Ltd. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ecopipam, a first-in-class investigational therapy for the treatment of pediatric Tourette syndrome.

“The NDA submission for ecopipam is a significant milestone for a potential first-in-class treatment option in pediatric Tourette syndrome,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva. “This reflects the momentum in our innovative pipeline through our recent acquisition of this important asset, and advances our Pivot to Growth strategy and commitment to bringing differentiated medicines for patients.”

The NDA submission is supported by positive Phase 3 data recently published in JAMA Neurology, which showed that ecopipam significantly delayed time to relapse compared with placebo in pediatric patients with Tourette syndrome who had achieved a clinical response during the open-label treatment period. In the study, ecopipam demonstrated a statistically significant benefit on the primary efficacy endpoint in pediatric patients (p = 0.008) and was generally well tolerated, with the most common adverse events related to ecopipam therapy including somnolence, insomnia, anxiety, fatigue and headache.