Zogenix’s FINTEPLA (fenfluramine), an oral solution CIV for the Treatment of Seizures Associated with Dravet Syndrome in patients aged 2 years and above gets approval from the U.S. Food and Drug Administration (FDA). Dravet syndrome is a childhood-onset epilepsy which occurs mostly after frequent and severe treatment-resistant seizures during the hospitalizations and medical emergencies, number significant developmental and motor impairments, and with an increased risk of sudden unexpected death (SUDEP).
Zogenix will launch FINTEPLA through a restricted distribution program, called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program, and company will launch it commercially by end of July and It will be available through company’s specialty pharmacy partner.
Zogenix will host a Conference Call for investors on June 26, at 8:30 AM ET / 5:30 AM PT to explain the details associated with FINTEPLA. ID for Conference is 13706215. Company provided the Toll Free and International numbers as 877-407-9716 and 201-493-6779, respectively. While access to webcast will be available at http://public.viavid.com/index.php?id=140519.
Zogenix sees the approval of FINTEPLA by the FDA as a significant milestone to celebrate with the patients and families having patients with Dravet syndrome.
President and Chief Executive Officer of the company Stephen J. Farr, Ph.D. said “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.”