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Zogenix Completes Enrollment in First ZX008 Phase 3 Clinical Trial in Dravet Syndrome

Study 1 Top-Line Data on Track for 3Q 2017

EMERYVILLE, Calif., April 27, 2017 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of orphan and central nervous system (CNS) disorders, today announced that the last patient has been randomized into the treatment period of Study 1, its first Phase 3 clinical trial evaluating ZX008 (low-dose fenfluramine) as an adjunctive treatment for seizures in children and young adults with Dravet syndrome.

"The completion of patient randomization in Study 1 is an important milestone for our ZX008 Phase 3 development program in Dravet syndrome," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We look forward to the availability of top-line data from this study, which we expect in the third quarter of this year. We are grateful for the participation of the patients, their families and the investigators involved in our ongoing clinical program."

Study 1 is a three-arm, fixed-dose, placebo-controlled trial with 40 subjects per treatment group being conducted in the U.S., Canada, Europe, and Australia. Randomized subjects are titrated to their target dose (0.2 or 0.8 mg/kg/day ZX008, maximum of 30 mg/day, or placebo) over two weeks and then held at that fixed dose for 12 weeks of maintenance treatment. Subjects who complete Study 1 are eligible to enter a long-term, open-label extension study.

In addition to Study 1, Zogenix is conducting a second double-blind, randomized...