Zogenix, Inc. announced the initiation of the first Phase 3 clinical trial for the Company's lead product candidate, ZX008, as an adjunctive treatment of seizures in children with Dravet syndrome. The Phase 3 program for ZX008 includes two randomized, double-blind placebo-controlled studies that will include two dose levels of ZX008 (0.2 mg/kg/day and 0.8 mg/kg/day, up to a maximum daily dose of 30 mg), as well as placebo. Zogenix intends to enroll 105 subjects in each of the two studies, with 35 patients in each treatment arm.

In addition to the U.S. Phase 3 study, a second multi-national study, which will be conducted primarily in Europe, is expected to initiate in the first quarter of 2016. The primary endpoint of both studies is the change in frequency of convulsive seizures as compared to placebo. The key secondary endpoints include 40% and 50% responder analyses and convulsive seizure-free interval.