February 8, 2018 Source: Biospace 123
Zogenix Announces Receipt of FDA Breakthrough Therapy Designation for ZX008 in Dravet Syndrome.
Designation Based on Positive Results from Study 1, the First Pivotal Phase 3 Trial of ZX008.
EMERYVILLE, Calif., Feb. 06, 2018 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational product, ZX008 (low-dose fenfluramine), for the treatment of seizures associated with Dravet syndrome.
FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines aimed at treating a serious or life-threatening disease where there is preliminary clinical evidence that the investigational therapy may offer substantial improvement over existing therapies on at least one clinically significant endpoint. FDA Breakthrough Therapy Designation for ZX008 is based on the results from Study 1, Zogenix’s first global Phase 3 trial of ZX008, which met the primary efficacy endpoint, as well as all prespecified key secondary efficacy endpoints.
“We are very pleased that the FDA has granted Breakthrough Therapy Designation based on the efficacy and safety results from Study 1 reported in fall of 2017,” said Gail M. Farfel, Ph.D., Chief Development Officer of Zogenix. “We look forward to working closely with the FDA as we conclude our Phase 3 clinical program in Dravet syndrome, a rare and catastrophic form of childhood epilepsy.”
ZX008 is designated as an orphan drug in both the U.S. and Europe for Dravet syndrome and Lennox-Gastaut syndrome, and has received Fast Track designation in the U.S. for the treatment of Dravet syndrome.
Zogenix (Nasdaq:ZGNX) is focused on developing therapies for patients with rare central nervous system (CNS) conditions that have limited or no treatment options but face a critical need.
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