Teva Pharmaceutical Industries has submitted a New Drug Application to the FDA for ecopipam, a first-in-class investigational therapy for pediatric Tourette syndrome. Ecopipam is a selective dopamine D1 receptor antagonist with a novel mechanism of action and has received both Orphan Drug and Fast Track designations from the FDA. If approved, it could become the first new FDA‑approved treatment option for pediatric Tourette syndrome in more than a decade.
The filing is supported by positive Phase 3 data recently published in JAMA Neurology, which showed that ecopipam significantly delayed time to relapse compared with placebo in pediatric patients with Tourette syndrome who had achieved a clinical response during an open‑label treatment period. In that study, ecopipam met the primary efficacy endpoint in pediatric patients, demonstrating a statistically significant benefit (p = 0.008). The drug was generally well tolerated, with the most common adverse events including somnolence, insomnia, anxiety, fatigue and headache.
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