Emalex Biosciences Seeks FDA Approval for Ecopipam to Treat Tourette Syndrome in Children
Emalex Biosciences is preparing to seek approval from the U.S. Food and Drug Administration (FDA) for ecopipam, a drug designed to treat children with motor and vocal tics caused by Tourette syndrome (TS). This follows a successful phase III clinical trial led by Dr. Donald Gilbert at Cincinnati Children's Hospital, which demonstrated that ecopipam can significantly reduce the risk of tic relapse in children. Unlike existing FDA-approved treatments for TS, which are antipsychotics initially approved for schizophrenia, ecopipam targets the dopamine D1 receptor, potentially offering fewer side effects. The trial involved 216 participants, with results showing a 50% reduction in relapse risk for those continuing ecopipam compared to a placebo. 
