Teva receives FDA priority review for Tourette drug

• Teva announced that the FDA accepted its New Drug Application for ecopipam and granted Priority Review for pediatric Tourette syndrome.
• The FDA assigned a targeted PDUFA action date in late Q1 2027 for the treatment candidate.
• Teva said Phase 2b and Phase 3 data showed statistically significant tic reduction compared with placebo.

Teva Pharmaceuticals (NYSE:TEVA) announced that the U.S. FDA accepted its New Drug Application for ecopipam (EBS-101) and granted Priority Review for pediatric Tourette syndrome.

The application seeks approval for ecopipam, a selective D1 receptor antagonist that Teva is developing as a potential treatment for children and adolescents with Tourette syndrome.

Teva said the NDA is supported by Phase 2b and Phase 3 clinical data showing statistically significant tic reduction and a 53% lower relapse risk over 12 weeks compared with placebo, with no clinically meaningful changes in weight, metabolic measures, ECG results, movement disorders or psychiatric measures.

The FDA assigned a targeted PDUFA action date in late Q1 2027 for ecopipam.

Ecopipam has received Orphan Drug designation, and Teva stated that the therapy could become the first new pediatric Tourette syndrome treatment in more than 10 years and the first novel mechanism of action in more than 50 years if approved.

Teva is developing ecopipam as part of its neuroscience portfolio, with the company continuing to evaluate treatments for neurological conditions.