Drugs

Teva NDA for Tourette Syndrome Accepted for Review

FDA has accepted for review a Teva Pharmaceuticals NDA for ecopipam, a company-described first-in-class investigational therapy for treating pediatric patients with Tourette syndrome. If approved, the drug would become the first new treatment option indicated for pediatric patients with Tourette’s in more than 10 years and the first novel mechanism of action in more than 50 years, the company says. The agency has set a user fee review action target date of 3/2027.

Teva says the submission is based on “positive Phase 2b and 3 data. In the Phase 2b study, patients receiving ecopipam experienced a reduction in tic severity, with statistically significant and clinically meaningful improvement in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) vs. placebo at Week 12.”

The Phase 3 randomized withdrawal study (published in JAMA Neurology) “further demonstrated maintenance of efficacy with ecopipam,” according to the company. “For the primary endpoint, pediatric ecopipam responders compared to placebo had a 53% decreased risk of relapse over 12 weeks.”

Ecopipam was “generally well-tolerated,” and the most common adverse events in pediatric patients with Tourette syndrome were headache, insomnia, fatigue, somnolence, tics, anxiety, nausea and restlessness,” Teva says.

Tourette syndrome is a nervous system condition that causes tics — sudden twitches, movements, or sounds that people do repeatedly, according to the CDC. Symptoms usually start in childhood between the ages of five and 10 years.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome