for pediatric Tourette syndrome
Sponsor announced submission . FDA filing review (~60 days) in progress; PDUFA date estimated as acceptance + 10 months Standard Review. Card updates with confirmed dates when FDA acceptance announcement lands.
Tourette syndrome is a neurodevelopmental disorder characterized by involuntary movements and vocalizations called tics. Ecopipam is an oral drug designed to block a specific dopamine receptor in the brain, a different target than older medications. By dampening this particular pathway, ecopipam may reduce tics without some of the side effects associated with other treatments.
This study was an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.
Source: ClinicalTrials.gov