Teva highlights positive efficacy and safety data for ecopipam

• Teva announced new pooled post hoc analysis data showing clinically meaningful tic improvement in 69.8% of pediatric Tourette syndrome patients taking ecopipam within eight weeks.
• An ongoing open-label extension study reported a 45.6% mean reduction in tic severity scores through 18 months, with no new safety signals identified.
• The company is advancing its pediatric application under FDA Priority Review as subsidiary data confirms that co-occurring psychiatric conditions do not negatively impact treatment efficacy.

Teva (NYSE:TEVA) announced new efficacy and safety analyses of ecopipam, its investigational treatment for pediatric patients with Tourette syndrome.

A pooled post hoc analysis found clinically meaningful tic improvement in 69.8% of 292 patients within eight weeks of treatment.

An interim analysis of an ongoing open-label extension reported a 45.6% mean reduction in tic severity scores through 18 months.

The long-term extension study included 118 participants with a median exposure of 14.9 months and revealed no new safety signals.

A separate post hoc analysis of 216 participants confirmed that common co-occurring psychiatric conditions did not negatively affect efficacy or safety during the 12-week period.

The investigational pediatric treatment is currently undergoing formal evaluation under U.S. FDA Priority Review.