Teva Reports the US FDA’s NDA Submission for Ecopipam to Treat Pediatric Tourette Syndrome
Shots:
- The US FDA has received an NDA for ecopipam, a selective dopamine D1 receptor antagonist, for the treatment of pediatric Tourette syndrome
- NDA was supported by the P-III trial data showing that ecopipam significantly delayed time to relapse vs PBO in pediatric Tourette syndrome pts who responded to treatment during the open-label treatment period; data were published in the JAMA Neurology
- Ecopipam is designed to block dopamine signaling at the D1 receptor, which received Orphan Drug & Fast Track designations from the FDA for the treatment of pediatric pts with Tourette syndrome
Ref: Teva | Image: Teva | Press Release
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