Teva Pharmaceutical Industries has submitted a New Drug Application (NDA) to the US FDA for ecopipam, a first-in-class investigational therapy aimed at treating 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, 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 filing is backed by positive Phase 3 results recently published in JAMA Neurology, showing ecopipam significantly delayed time to relapse compared with placebo in children who had previously responded during the open-label phase. 

 

The trial reported a statistically significant benefit on the primary efficacy endpoint in pediatric patients, with the drug generally well tolerated. The most commonly reported adverse events included somnolence, insomnia, anxiety, fatigue and headache.

 

Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics that typically begin in childhood, usually between ages 5 and 10. 

 

While existing treatments are available, many patients still experience inadequate symptom control or side effects that limit use, highlighting a continued need for new therapeutic options.