Zogenix received fast track designation from the FDA for ZX008 as a treatment of seizures associated with Dravet syndrome.
Fast track designation facilitates the development and expedites the review of drugs with the potential to treat serious conditions and address unmet medical needs.
What is Dravet Syndrome?
Dravet syndrome is a rare and severe form of intractable epilepsy that begins in infancy. Symptoms include long lasting seizures, behavioral and developmental delays, movement and balance issues, sleeping difficulties, chronic infections, sensory integration disorders and disruptions to the autonomic nervous system.
Worldwide birth prevalence is thought to be less than 1 in 40,000 infants. Currently there are no orphan drugs approved for this condition however there are some drugs in development, including cannabidiol
The FDA accepted Zogenix’s IND application for ZX008 back in December and is planning a phase 3 program that will consist of 2 randomized, double-blind placebo-controlled studies that will include 2 dose levels of ZX008 (0.2 mg/kg/day and 0.8 mg/kg/day, up to a maximum daily dose of 30 mg), as well as placebo. Zogenix intends to enroll 105 subjects in each of the 2 studies, with 35 patients in each treatment arm. One study will be conducted primarily in the US and Canada, and the other will be a multi-national study, conducted primarily in Europe. The primary endpoint will be the change in frequency of convulsive seizures as compared to placebo. The key secondary endpoints include 40% and 50% responder analyses and convulsive seizure-free interval.
“The FDA granting Fast Track designation provides important support as we advance the development program for ZX008 in Dravet syndrome towards a potential approval as quickly as possible,” said Stephen Farr, PhD, CEO of Zogenix. “We recently initiated our first Phase 3 clinical trial in the U.S., and the second trial, primarily to be conducted in Europe, is expected to begin this quarter.”
For more information about the trial or to see if your patient qualifies, please visit the clinical trial webpage here
Zogenix Receives Fast Track Designation From FDA for Development of ZX008 in Dravet Syndrome [new release]. Emeryville, CA; Zogenix Inc.: January 19, 2015. http://globenewswire.com/news-release/2016/01/19/802887/0/en/Zogenix-Receives-Fast-Track-Designation-From-FDA-for-Development-of-ZX008-in-Dravet-Syndrome.html