EMERYVILLE, Calif., Feb. 06, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (ZGNX), a global pharmaceutical company developing rare disease therapies, today announced it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for FINTEPLA (ZX008, low-dose fenfluramine) for the treatment of seizures associated with Dravet syndrome. Dravet syndrome is an intractable and difficult-to-treat epilepsy that begins in infancy and is associated with frequent, severe, and potentially life-threatening seizures, developmental delay, and cognitive impairment.i,ii
Both applications are based on data from two pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months.
“Our concurrent submissions to the FDA and EMA are the culmination of four years’ effort for Zogenix, our investigators, and the families who participated in the ZX008 clinical trial program,” said Stephen J. Farr, President and Chief Executive Officer of Zogenix. “We are honored to have partnered with such dedicated people to develop a potential new treatment for this rare and often catastrophic disease and look forward to working closely with the FDA and EMA during the review process.”
Zogenix is also investigating FINTEPLA in Lennox-Gastaut syndrome, another rare childhood-onset epilepsy, for which a Phase 3 trial is ongoing.
About Dravet Syndrome
Dravet syndrome is a rare form of intractable (treatment-resistant) epilepsy that begins in infancy and is associated with frequent, severe, and potentially life-threatening seizures, developmental delay, cognitive impairment, and an elevated risk of sudden unexplained death in epilepsy (SUDEP).i,ii Early estimates on the incidence of Dravet syndrome ranged from one in 20,000 to one in 40,000; however more recent research suggests the incidence may be as frequent as one in 15,700.iii The disease also has an impact on the entire family, often resulting in substantial financial, physical, psychosocial and emotional burdens.
Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. For more information, visit www.zogenix.com.
Forward Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential timing of acceptance and approval, if any, by the FDA and the EMA of the NDA and MAA, respectively, for FINTEPLA; Zogenix’s plans regarding the development of FINTEPLA in Lennox-Gastaut syndrome; the need for FINTEPLA to address unmet medical need; and the patient population. These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the FDA may disagree that the existing safety and efficacy data is sufficient to allow an NDA review and approval, the FDA may not agree with Zogenix’s interpretation of the results of the clinical trials of FINTEPLA; additional data from Zogenix’s ongoing studies may contradict or undermine the data submitted in the NDA for FINTEPLA; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
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i National Organization for Rare Disorders. Dravet syndrome. https://rarediseases.org/rare-diseases/dravet-syndrome-spectrum.
ii Wirrell EC, Laux L, Donner E, et al. Optimizing the diagnosis and management of Dravet syndrome: Recommendations from a North American consensus panel. Pediatr Neural. 2017; 68: 18-34.
iii Wu YW, Sullivan J, McDaniel S, et al. Incidence of Dravet Syndrome in a US Population. Pediatrics. 2015; 3.