FDA accepts Teva's drug application for Tourette syndrome therapy in children

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), announced that the U.S. Food and Drug Administration accepted a New Drug Application for ecopipam, an investigational treatment for Tourette syndrome in pediatric patients, with a target action date in the first quarter of 2027.

The FDA granted Priority Review and Orphan Drug designation to ecopipam, which Teva describes as a first-in-class therapy that blocks dopamine signaling at the D1 receptor. Orphan Drug designation applies to treatments targeting populations of 200,000 or fewer patients.

The NDA is supported by Phase 2b and Phase 3 clinical trial data. In the Phase 2b trial, patients receiving ecopipam showed statistically significant improvement in tic severity versus placebo at week 12 on the Yale Global Tic Severity Scale-Total Tic Score (P = 0.01). The Phase 3 randomized withdrawal study, published in JAMA Neurology, found that ecopipam responders had a 53% reduced risk of relapse over 12 weeks compared to placebo (p=0.008).

Across clinical trials, no clinically meaningful changes were observed in body weight, metabolic parameters, electrocardiogram measurements, or drug-induced movement disorders. The most commonly reported adverse events included headache, insomnia, fatigue, somnolence, tics, anxiety, nausea, and restlessness.

"If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first novel mechanism of action in more than 50 years," said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva.

Tourette syndrome is a neuro-developmental disorder affecting approximately 100,000 children and adolescents in the United States. According to the press release, only half of those patients receive prescription treatment, and 20 to 30 percent remain on therapy after one year.

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