Zogenix announced that it has submitted a New Drug Application (J-NDA) to the Japanese Ministry of Health, Labour & Welfare (MHLW) for the marketing approval of FINTEPLA® (fenfluramine) for the treatment of epileptic seizures associated with Dravet syndrome in Japan. FINTEPLA received Orphan Drug Designation from Japan’s Ministry of Health, Labour & Welfare (MHLW) in August 2021. The submission is supported by the results of Study 3, a multi-national randomized, double-blind, placebo-controlled, Phase 3 study, of 143 children and young adults with Dravet syndrome, including trial participants from Japan, whose seizures were not adequately controlled by existing anti-epileptic drugs. Study 3 met its primary objective in demonstrating that patients in the FINTEPLA 0.7 mg/kg/day group achieved a 64.8% greater reduction in mean monthly convulsive seizures compared to the placebo group (p<0.0001). FINTEPLA was generally well-tolerated in this study, with adverse events consistent with those observed in previous Phase 3 studies, Study 1 and Study 2, and with the known safety profile of fenfluramine.