7/103 sources · 3 publishersUpdated Oct 8, 19:42 UTC
Teva presents new ecopipam data for pediatric Tourette syndrome
Teva Pharmaceuticals presented post hoc and interim data for investigational ecopipam at a movement-disorders congress in Seoul. In an ongoing open-label extension, tic-severity scores declined by a mean 45.6% through 18 months, with no new safety signals reported. Ecopipam is under FDA Priority Review for pediatric Tourette syndrome.
Why it matters
The data add longer-term safety and efficacy evidence while the FDA reviews ecopipam. Teva says the findings strengthen its confidence that the treatment could become a new option for pediatric Tourette syndrome if approved.
Key facts
- 1An interim open-label extension analysis reported a mean 45.6% reduction in tic-severity scores through 18 months, with no new safety signals. globenewswire.com
- 2The extension analysis included 118 children, adolescents and adults who received at least one ecopipam dose and had median treatment exposure of 14.9 months. globenewswire.com
- 3Teva said ecopipam has FDA Priority Review and Orphan Drug designation for pediatric Tourette syndrome. globenewswire.com
- 4A post hoc Phase 3 analysis compared 216 participants aged ≥6 years, including 129 with and 87 without common psychiatric conditions. globenewswire.com
- 5Material 3 reports that the FDA action date is expected in late Q1 2027. clinicaltrialvanguard.com
Open questions
- Material 1 describes the early tic-response rate as approximately 70% in its summary but gives 69.8% in the detailed study results.
- The exact FDA action date was not provided; material 3 characterizes it only as late Q1 2027.
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.