SILVER SPRING
Ecopipam NDA accepted with priority review for pediatric Tourette syndrome
- Sponsor
- Teva Pharmaceuticals $TEVA
- Drug
- ecopipam
- Indication
- pediatric Tourette syndrome
FDA accepted Teva's NDA and granted priority review for ecopipam, a first-in-class therapy for pediatric Tourette syndrome.
What this means
Ecopipam is an oral pill that works by blocking dopamine, a brain chemical involved in involuntary tics. Today the FDA accepted Teva's application for the drug's use in children with Tourette syndrome and will grant it a faster, six-month review. The agency recommends healthcare professionals "inform patients and their caregivers of the potential for suicidality and depression and advise them to watch for the emergence or worsening of these symptoms.