Fast Track designation is received when a potential new therapy is intended to treat a serious condition and data demonstrate the potential to address an unmet medical need. This designation signals FDA’s interest in the development program for ecopipam for the treatment of pediatric patients with TS, the ability to request a rolling new drug application (NDA) submission, as well as the potential for expedited NDA review.
“We are encouraged that the FDA has granted Fast Track designation to ecopipam for the treatment of patients with TS, a serious disease with significant morbidity,” said Atul Mahableshwarkar, MD, Senior Vice President of Drug Development at Emalex. “The unmet medical need for patients with TS is significant and we look forward to working with the FDA throughout the development process for this novel compound.”
Ecopipam selectively blocks the actions of dopamine at the D1 receptor. Previous Phase 2 studies in both adult and pediatric patients with TS have suggested potential activity in reducing the frequency and severity of motor and vocal tics associated with TS. Earlier this month, Emalex announced that the company had initiated enrollment 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 centers in the United States, Canada, and the European Union.
Source: Company Press Release