Zogenix, Inc. reported positive top-line results from its second confirmatory Phase 3 study (Study 1504) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of children and young adults with Dravet syndrome. The study results, which are consistent with those reported in Study 1, Zogenix’s first pivotal Phase 3 study, successfully met the primary endpoint and all key secondary endpoints, demonstrating that ZX008, at a dose of 0.5 mg/kg/day (maximum 20 mg/day), is superior to placebo when added to a stiripentol regimen.
July 12, 2018
November 16, 2019
Results of a Randomized Study of the Safety and Efficacy of Cenobamate in Adults with Uncontrolled Focal Seizures Published in The Lancet Neurology
The results of the study demonstrated that adjunctive treatment with cenobamate produced significant reductions in seizures compared to placebo.