USFDAJun 18, 2026, 04:58 PM
Teva Submits NDA for Ecopipam for Pediatric Tourette Syndrome
AI Summary
Teva Pharmaceutical Industries Ltd. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ecopipam. This investigational therapy is a potential first-in-class treatment for pediatric Tourette syndrome and has received FDA Orphan Drug and Fast Track designations. The NDA is supported by positive Phase 3 data, recently published in JAMA Neurology, which demonstrated that ecopipam significantly delayed time to relapse compared with placebo and was generally well-tolerated. This submission represents a significant milestone for Teva's innovative pipeline and its "Pivot to Growth" strategy.
Key Highlights
- Teva submitted a New Drug Application (NDA) to the FDA for ecopipam for pediatric Tourette syndrome.
- Ecopipam is a first-in-class selective dopamine D1 receptor antagonist.
- Ecopipam received FDA Orphan Drug and Fast Track designations.
- NDA supported by positive Phase 3 data published in JAMA Neurology.
- Phase 3 study showed statistically significant benefit (p = 0.008) on primary efficacy endpoint.
- Ecopipam significantly delayed time to relapse compared to placebo.
- Most common adverse events included somnolence (11.1%), anxiety (9.7%), and headache (9.7%).
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