Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), which develops medicines across neuroscience and immunology, on Friday released new analyses supporting ecopipam for paediatric Tourette syndrome.

Ecopipam is a first-in-class investigational selective D1 receptor antagonist designed to block dopamine signalling. It has FDA Priority Review and Orphan Drug designation for paediatric Tourette syndrome.

A pooled post hoc analysis of 292 Phase 2b and Phase 3 participants showed that 69.8% achieved a clinically meaningful reduction in Yale Global Tic Severity Scale Total Tic Score within eight weeks. Somnolence and headache were the most common adverse events, typically occurring during early treatment.

An interim 18-month analysis from an ongoing 36-month open-label extension study reported a mean tic severity reduction of 45.6% and no new safety signals. Among 118 treated children, adolescents and adults, the most frequent adverse events included anxiety and insomnia.

A separate post hoc analysis of 216 Phase 3 participants found that co-occurring psychiatric conditions such as ADHD, OCD, anxiety and depression did not affect efficacy or safety. Mean tic severity reductions and overall tolerability were consistent between those with at least one co-occurring condition and those without.

The clinical programme includes the D1AMOND Phase 2b trial, its open-label extension and the D1AMOND Phase 3 withdrawal trial, which together evaluated short-term efficacy, long-term safety and maintenance of response. Although adults were included in Phase 3, Teva's regulatory submission seeks approval solely for paediatric use.