The Only FDA-Approved CBD Treatment For Severe Epilepsy Completes Key Phase 3 Trial In Japan Despite Missed Primary Goal
Jazz Pharmaceuticals (NASDAQ:JAZZ) reported results from a Phase 3 trial in Japan evaluating the safety and efficacy of cannabidiol oral solution, Epidiolex, for treating seizures in children with rare forms of epilepsy, such as Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex.
While the trial did not achieve its primary goal of a significant reduction in seizure frequency, there were numeric improvements in other areas. Importantly, no new safety issues were found.
“We are confident in the overall clinical profile ofEpidiolex, which has been established in five Phase 3 clinical trials in more than 900 patients,” stated Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. “We believe the totality of the Epidiolexglobal data, …