Zogenix, Inc. announced positive new data for its investigational drug, FINTEPLA® (ZX008, fenfluramine), for the treatment of seizures associated with Dravet syndrome. The data were presented in five scientific posters, available here, at the recent Childhood Neurology Society (CNS) Congress. The posters include data showing long-term, clinically meaningful reduction in convulsive seizure frequency in young Dravet syndrome patients (under 6 years of age) in an ongoing Open-Label Extension (OLE) study, as well as data from a post-hoc analysis showing clinically meaningful and profound reduction in the frequency of high-risk tonic-clonic (grand-mal) seizures in Dravet syndrome patients treated in two previously completed Phase 3 clinical trials. Other data include the results of a Phase 1 study to assess the potential drug-drug interaction of fenfluramine and cannabidiol (CBD).
“These data continue to demonstrate the significant clinical impact Fintepla has shown in studies of Dravet syndrome patients,” said Bradley Galer, M.D., Executive Vice President and Chief Medical Officer at Zogenix. “These new results clearly show the impact this drug candidate has had on some of the most vulnerable patients, those who are younger than 6 years of age, as well as those suffering from generalized tonic-clonic seizures, a recognized risk factor for sudden unexplained death in epilepsy (SUDEP).”