Teva (TEVA) said late Thursday it submitted a new drug application to the US Food and Drug Administration for ecopipam investigational therapy to treat pediatric Tourette syndrome, a chronic neuro-developmental disorder.

The NDA submission is supported by phase 3 data, which showed ecopipam sharply delayed time to relapse compared with placebo in pediatric Tourette patients who had attained a clinical response during the open-label treatment period, the company said.

Ecopipam has secured Orphan Drug and Fast Track designations from the FDA for the treatment of Tourette syndrome in pediatric patients, according to a statement.