Zogenix Announces Presentation of New Efficacy and Safety Data from its First Pivotal Phase 3 Clinical Trial

Zogenix (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today announced additional data from analyses of its first Phase 3 trial (Study 1) of the Company’s investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the adjunctive treatment of seizures associated with Dravet syndrome.

As quoted in the press release:

Top-line results from Study 1 were previously reported in September 2017. The additional Study 1 results were presented in two late-breaker poster presentations at the Emerging Science session at the 2018 American Academy of Neurology (AAN) Annual Meeting being held April 21-27 in Los Angeles, California (see study data here and here).

As previously reported, Study 1 met its primary objective of demonstrating that ZX008, at a dose of 0.8 mg/kg/day, is superior to placebo as an adjunctive therapy in the treatment of Dravet syndrome in children and young adults based on change in the frequency of convulsive seizures between the 6-week baseline observation period and the 14-week treatment period (p<0.001).

The first poster, presented by Elaine C. Wirrell, M.D., Director of Pediatric Epilepsy at the Mayo Clinic, showed the results of a post-hoc analysis evaluating the effect of ZX008 in enrolled patients in Study 1 who had previously failed treatment with stiripentol, which is currently the only medication for adjunctive treatment of seizures in patients with Dravet syndrome, approved in Europe, Australia, Canada, and Japan, and available via compassionate use in the U.S.

Click here to read the full press release.