The investigational compound Clobazam, is marketed under the brand names Frisium and Urbanol, is a drug which is a benzodiazepine derivative.
Lundbeck announced Onfi as the proposed US trade name for clobazam.
Lundbeck has submitted the NDA on the basis of the positive results from a Phase III trial which evaluated the safety and efficacy of Onfi as add-on therapy in patients with LGS.
Lundbeck Global Regulatory Affairs vice president Timothy Cunniff said the FDA’s acceptance for review of the Onfi NDA represents a significant milestone for Lundbeck as we work to improve the lives of people living with epilepsy.