News Release

Zogenix to Present New Data for Its Investigational Drug FINTEPLA® at the American Epilepsy Society Annual Meeting


EMERYVILLE, Calif., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, announced that data from eight abstracts related to its investigational therapy, FINTEPLA® (ZX008, fenfluramine oral solution), for the treatment of seizures associated with Dravet syndrome will be presented at the American Epilepsy Society (AES) Annual Meeting being held in Baltimore, MD, from December 6-10, 2019. Below are the titles of the eight posters that will be presented at the 2019 AES Annual Meeting. Authors will be available to answer questions on their posters at the times specified below.

In addition to the posters, Zogenix will host a Scientific Exhibit Room on Sunday, December 8, from 8:00 – 11:00 am Eastern Time (ET).

Saturday, December 7
General Poster Session 1, 12:00 - 6:00 pm ET, Level 100, Hall E/F

  1. FINTEPLA® (ZX008, Fenfluramine Hydrochloride Oral Solution) in Dravet Syndrome: Comparison of Study 1 Results Using 4-Week Versus 6-Week Baseline Seizure Collection (J. Sullivan, G. Morrison, M. Lock, G. Farfel) – Poster #217
  2. Caregiver Benefit and Caring for a Child with an Epileptic Encephalopathy (D. Amtmann, A. Bamer, A. Gammaitoni, et al) – Poster #419

Sunday, December 8
General Poster Session 2, 10:00 am - 4:00 pm ET, Level 100, Hall E/F

  1. Evaluation of the Acute Anticonvulsant Efficacy of Fenfluramine in Mouse Models of Acute and Chronic Seizures (P. Martin, S. White, M. Barker-Haliski) – Poster #203
  2. Fenfluramine in Dravet Syndrome: Re-analysis of Study 1 Using Time-to-Event to Measure Treatment Effect (D. Dlugos, J. French, M. Lock, et al) – Poster #224
  3. Profound Reduction in Seizure Frequency (≥75%) Leads to Improved Everyday Executive Function: Analysis From a Phase 3 Study of ZX008 (Fenfluramine HCl) in Children/Young Adults With Dravet Syndrome (K. Bishop, P. Isquith, G. Gioia, et al) – Late Breaker Poster #438

Monday, December 9
General Poster Session 3, 8:00 am - 2:00 pm ET, Level 100, Hall E/F

  1. The Action of Fenfluramine to Prevent Seizure-Induced Death in the DBA/1 Mouse SUDEP Model is Selectively Blocked by an Antagonist or Enhanced by an Agonist for the Serotonin 5-HT4 Receptor (C. Faingold, S. Tupal) – Poster #292
  2. ZX008 (Fenfluramine Hydrochloride) Provides Clinically Meaningful Reduction in Seizure Frequency Irrespective of Concomitant AEDs Commonly Used in Dravet Syndrome: Pooled Analysis of 2 Phase 3 Trials (K. Knupp, L. Lagae, E. Thiele, et al)
    – Late Breaker Poster #430
  3. Fenfluramine Reduces Seizure Burden by Significantly Increasing Number of Seizure-Free Days and Time Between Seizures in Patients with Dravet Syndrome (J. Sullivan, O. Devinsky, B. Galer, et al) – Late Breaker Poster #431

About Zogenix
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. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.  Zogenix’s New Drug Application for FINTEPLA for Dravet syndrome has been accepted for review by the U.S. Food & Drug Administration; its application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan.

Forward-Looking Statement
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 top-line data for Zogenix’s Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome (Study 1601). 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 timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA; 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.


Melinda Baker
Senior Director, Corporate Communications
+1 (510) 788-8732 |

Andrew McDonald
Founding Partner, LifeSci Advisors LLC
+1 (646) 597-6987 |


Source: Zogenix, Inc