Teva Pharmaceuticals Submits NDA for Tourette Syndrome Drug to FDA
The company states: "Teva Pharmaceutical announced the submission of a New Drug Application to the U.S. Food and Drug Administration for ecopipam, a first-in-class investigational therapy for the treatment of pediatric Tourette syndrome. 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 and was generally well tolerated, with the most common adverse events related to ecopipam therapy including somnolence, insomnia, anxiety, fatigue and headache."
