FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome

- FINTEPLA® significantly and substantially reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, as observed in two phase 3 placebo-controlled clinical trials

- Commercial launch planned for July 2020

EMERYVILLE, CA, USA I June 25, 2020 I Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA will be launched through a restricted distribution program, called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program, and is expected to be available through Zogenix's specialty pharmacy partner by the end of July.

"The approval of FINTEPLA by the FDA is a significant milestone we are proud to celebrate with the patients and families living with Dravet syndrome," said Stephen J. Farr, Ph.D., President and Chief Executive Officer of Zogenix. "We began this global development program nearly six years ago after researchers in Belgium recognized the potential of fenfluramine, a drug with distinct pharmacology from all other anticonvulsant agents, to treat intractable seizures in Dravet syndrome. Our heartfelt gratitude goes to the patients, families, and everyone who supported the rigorous development program that led to FINTEPLA's approval."

Dravet syndrome is a rare childhood-onset epilepsy marked by frequent and severe treatment-resistant seizures, associated hospitalizations and medical emergencies, significant developmental and motor impairments, and an increased risk of sudden unexpected death (SUDEP).

"There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available anti-seizure medications," said Joseph Sullivan, M.D., Director of the Pediatric Epilepsy Center of Excellence at the UCSF Benioff Children's Hospitals and the Principal Investigator for FINTEPLA in Dravet syndrome. "Given the profound reductions in convulsive seizure frequency seen in the FINTEPLA clinical trials, combined with the ongoing, robust safety monitoring that will be part of its use, I feel FINTEPLA will offer an extremely important treatment option for Dravet syndrome patients."

The FDA's approval of FINTEPLA in Dravet syndrome was based on data from two randomized, double-blinded, placebo-controlled Phase 3 clinical trials, published in The Lancet1 and JAMA Neurology2, and safety data from an open-label extension trial in which many patients received FINTEPLA for up to three years. When added to existing treatment regimens, FINTEPLA significantly reduced the monthly convulsive seizure frequency compared to placebo in study patients whose seizures were not adequately controlled on one or more antiepileptic drugs. In addition, most study patients responded to treatment with FINTEPLA within three to four weeks and effects remained consistent over the treatment period.

The most common adverse reactions (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus.

FINTEPLA will be available to certified prescribers in the U.S. in July. Zogenix is launching Zogenix Central™, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information is available at www.FINTEPLA.com to assist patients and their families.

"Having a new FDA-approved treatment option is so important because it improves our ability to optimize each patient's treatment," said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. "Moreover, because families living with Dravet syndrome never know when the next seizure is going to occur, whether they will end up in the E.R., or what the consequences might be following the seizure, having a strong support program like Zogenix Central to reduce the strain on families is very welcome. This will allow family members to remain focused on providing the best care of their loved one with Dravet."

About Dravet Syndrome
Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death. Despite existing therapies, there remains a great unmet need in Dravet syndrome to reduce convulsive seizures that can lead to medical emergencies, hospitalizations, and SUDEP (sudden unexpected death in epilepsy). The severity and unpredictability of the disease, coupled with around-the-clock concern for the diagnosed child's well-being, can present significant emotional and logistical challenges for all members of the family. 

About FINTEPLA® (fenfluramine) oral solution, CIV
FINTEPLA is an approved treatment, in the U.S., for seizures associated with Dravet syndrome in patients 2 years of age and older. Across multiple clinical studies, FINTEPLA demonstrated significant and sustained reduction of convulsive seizures associated with Dravet syndrome. In two pivotal Phase 3 trials, the reduction in convulsive seizure frequency per 28 days was statistically significantly greater for all dose groups of FINTEPLA compared to placebo.

About Zogenix
Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and one for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

¹ The Lancet, Volume 394, Issue 10216, P2243-2254, December 21, 2019
² JAMA Neurol. 2020 Mar; 77(3): 300–308.

SOURCE: Zogenix

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