EMERYVILLE, Calif., Sept. 26, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it has resubmitted its New Drug Application (NDA) for FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome to the U.S. Food and Drug Administration (FDA).
“We believe that FINTEPLA, if approved, could become an important new treatment option for patients and families living with Dravet syndrome,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “We appreciate the FDA’s guidance through the resubmission process and look forward to continuing to work closely with the Agency during their review of our application.”
The NDA is 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 24 months. Zogenix is also investigating FINTEPLA in Lennox-Gastaut syndrome, another rare childhood-onset epilepsy, for which a Phase 3 trial is ongoing and top-line data are anticipated in the first quarter of 2020.
Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies that improve the lives of patients and their families living with serious rare diseases. The Company has two late-stage drug candidates: FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndrome, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, an investigational deoxynucleoside substrate enhancement therapy for the treatment of Thymidine Kinase 2 deficiency (TK2d), an inherited mitochondrial DNA depletion disorder. Zogenix’s NDA for FINTEPLA in Dravet syndrome has been resubmitted to the FDA and an MAA for the same indication is under review by the European Medicines Agency. FINTEPLA is also in development in Japan. The Company anticipates top-line data for FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020.
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: Zogenix’s belief that the re-submitted NDA will be accepted for filing by the FDA; the potential for FINTEPLA, if approved, to provide an important new treatment option for patients and families living with Dravet syndrome; and the potential timing of top-line data the on-going Phase 3 trial of FINTEPLA in patients with Lennox-Gastaut syndrome (LGS). 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 not accept the resubmitted NDA; the FDA may disagree that the existing safety and efficacy data is sufficient to approve the NDA; the FDA may require Zogenix to conduct the additional chronic toxicity studies noted in the Refusal to File letter, dated April 3, 2019, or other studies or information in connection with its review of the NDA; the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the results of Study 1601 may differ from the results of prior clinical studies in LGS or may demonstrate adverse safety data compared to the prior Phase 3 clinical trials of FINTEPLA; the FDA may not agree with Zogenix’s interpretation of the results of the clinical trials of FINTEPLA; later developments with the FDA that may be inconsistent with feedback received at prior meetings with the FDA; 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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