Posted by Michael Wonder on 29 Aug 2019
Emalex Biosciences receives FDA fast track designation for ecopipam for the treatment of patients with Tourette syndrome
28 August 2019 - Emalex Biosciences announced today that it has received fast track designation for its investigational product, ecopipam, from the U.S. FDA for the treatment of patients with Tourette syndrome.
Ecopipam selectively blocks the actions of dopamine at the D1 receptor. Previous Phase 2 studies in both adult and paediatric patients with TS have suggested potential activity in reducing the frequency and severity of motor and vocal tics associated with Tourette syndrome (TS). Earlier this month, Emalex announced that the company had initiated enrolment into a Phase 2b double-blind clinical study of ecopipam in children and adolescent patients (aged >6 to <18 years) with TS at multiple study centres in the United States, Canada, and the European Union.
