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Zogenix announces positive results for ZX008 in Dravet syndrome
EMERYVILLE, Calif.—Zogenix Inc., a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, in July 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.
According to Zogenix, the 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. The results are consistent with those reported in Study 1, Zogenix’s first pivotal Phase 3 study, the company adds.
Keys finding include:
“These impressive study results show the significant impact the addition of ZX008 made in reducing the burden of convulsive seizures for patients who are not adequately controlled using stiripentol, the standard of care for the treatment of Dravet syndrome in Europe,” said Dr. Rima Nabbout of the Department of Pediatric Neurology, Reference Center for Rare Epilepsies at Necker Enfants Malades Hospital, who was the principal investigator of Study 1504. “If approved, ZX008 has the potential to be a transformative treatment for Dravet syndrome, a rare and serious form of epilepsy with few available treatment options.”