Benzinga | Dec 21, 2020 08:03AM EST

The European Commission Approves Zogenix's FINTEPLA Oral Solution for the Treatment of Seizures in Dravet Syndrome

* Dravet syndrome is a rare, debilitating and difficult-to-treat lifelong epilepsy that begins in infancy

* EC approval is based on Phase 3 study data demonstrating that FINTEPLA safely and significantly reduced convulsive seizure frequency for Dravet syndrome patients whose seizures were not adequately controlled on existing medications, including stiripentol

* First EU market launch planned for Germany in Q1 2021

EMERYVILLE, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, announced today that the European Commission (EC) has granted marketing authorization for FINTEPLA(r) (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. Dravet syndrome is a rare, lifelong epilepsy that begins in infancy and is marked by severe refractory seizures, frequent medical emergencies, significant cognitive and behavioral impairments, and an increased risk of sudden premature death (SUDEP).

"We deeply appreciate the physicians and Dravet community whose support led to this important milestone," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "With the EC approval in place, we can now begin making FINTEPLA more widely available for the treatment of Dravet syndrome patients in Europe who seek new safe and effective treatment options."

The EC's approval of FINTEPLA was based on positive safety and efficacy results from two randomized, international, multi-center, placebo-controlled Phase 3 trials (Study 1 and Study 2), as well as data from an interim analysis of a long-term, open-label extension study in 330 Dravet syndrome patients treated up to 3 years.

"After a healthy start in life, children with Dravet syndrome suffer from frequent and prolonged epileptic seizures, which determine the future of the child and mean that parents are on constant alert. Current treatments for Dravet syndrome are unsatisfactory, resulting in the disease affecting motor and mental development," said Dr. Tilman Polster, a pediatric epilepsy specialist at the Mara Hospital of the Bethel Epilepsy Centre in Bielefeld, Germany, and primary investigator for fenfluramine oral solution in Dravet syndrome in Germany. "Experience from clinical studies has shown that FINTEPLA offers an impressive reduction in seizures, plus an improvement in quality of life. In conjunction with the ongoing data being collected on the safety profile of the therapy, FINTEPLA represents an effective new treatment option and an important hope for the families concerned."

When added to other antiepileptic therapies, including stiripentol, FINTEPLA provided a highly statistically significant and clinically meaningful reduction in convulsive seizure frequency. The most commonly reported adverse events that occurred in patients treated with this included decreased appetite, diarrhea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis.

With this approval, and subject to price and reimbursement being implemented according to national regulations, Zogenix will be able to market FINTEPLA in all European Union member countries, and in the United Kingdom, Norway, Iceland, and Liechtenstein.