Regulatory2026-10-02

Ecopipam (EBS-101) - (D1AMOND)

Teva Pharmaceutical Industries LimitedTEVA
Indication
Tourette syndrome
Stage
phase5
Event
Regulatory Decision
Details

October 2, 2026: Teva Pharmaceuticals (NYSE and TASE: TEVA) reported new ecopipam data in pediatric Tourette syndrome for presentation at the International Congress of Parkinson’s Disease and Movement Disorders (October 4–8, 2026). Ecopipam is under FDA Priority Review with Orphan Drug designation for pediatric Tourette syndrome.

In a pooled post hoc analysis of 292 patients from Phase 2b and Phase 3 trials, 69.8% achieved a clinically meaningful Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS) reduction of at least 25% within 8 weeks. Common adverse events in the first 8 weeks included somnolence and headache.

An interim analysis of an ongoing 36-month open-label extension study in 118 patients with Tourette syndrome (median exposure 14.9 months) showed ecopipam maintained clinically meaningful tic suppression through 18 months, with a mean tic severity reduction of 45.6% and no new safety signals. Common adverse events included nasopharyngitis, upper respiratory tract infection, anxiety, diarrhea, influenza, pyrexia, and insomnia.

A post hoc Phase 3 subgroup analysis of 216 participants found common co-occurring psychiatric conditions including ADHD, OCD, anxiety, and depression did not negatively affect tic reduction, safety, or tolerability during the 12-week open-label period. Teva said its accepted NDA seeks a pediatric-only indication.