Teva reports early and durable tic reductions for ecopipam in Tourette studies
Teva Pharmaceuticals presented pooled and interim clinical analyses of ecopipam, its investigational treatment for pediatric Tourette syndrome, at the International Congress of Parkinson’s Disease and Movement Disorders. The company reported improvements in tic severity early in treatment and persistence of tic control in a long-term extension study. Ecopipam is under FDA Priority Review for pediatric Tourette syndrome, with an action date targeted in Q1 2027.
Why it matters
Teva said the findings increase its confidence that ecopipam could address pediatric Tourette syndrome. The FDA review outcome will determine whether Teva can commercialize the medicine for this use.
Key facts
- 1In a pooled analysis of Phase 2b and Phase 3 trials, 69.8% of 292 participants achieved at least a 25% decline from baseline in YGTSS-TTS within the first 8 weeks of ecopipam treatment. neurologylive.com
- 2In the Phase 3 randomized-withdrawal study, relapse occurred in 41.9% of pediatric participants remaining on ecopipam and 68.1% of those moved to placebo. neurologylive.com
- 3Teva reported a 53% relative reduction in relapse risk for pediatric participants who continued ecopipam, with HR, 0.50; P =.008. neurologylive.com
- 4An interim 36-month open-label extension analysis covered 118 participants with median treatment exposure of 14.9 months. neurologylive.com
- 5At 18 months, the interim extension analysis showed a mean 45.6% reduction in YGTSS-TTS. neurologylive.com
- 6Ecopipam has FDA Priority Review for pediatric Tourette syndrome, and the target action date is Q1 2027. neurologylive.com
Open questions
- The reported analyses include post hoc and interim results, and the FDA has not yet decided on approval of ecopipam.
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.