Zogenix Launches Global Access Program for FINTEPLA® (Fenfluramine) Oral Solution
- FINTEPLA is approved in the
U.S.and European Unionas an add-on therapy for the treatment of seizures associated with Dravet syndrome in patients aged two years and older.
- The new program supports physician access to FINTEPLA in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established.
“Three randomized clinical studies have demonstrated FINTEPLA's ability to provide transformational and durable seizure reduction for many Dravet syndrome patients whose seizures were not adequately controlled despite treatment with one or more other anti-epileptic medicines,” said
“We are delighted to be working in partnership with
About the Zogenix Access Program
The Zogenix Access Program is for physicians who are interested in treating their patients with FINTEPLA in countries where it is not yet available commercially or through local access schemes. The program does not provide free-of-charge access to FINTEPLA and does not affect patients already taking FINTEPLA as part of a clinical study. Specifics of the program may vary by country based on local regulations.
Physicians can learn more about the
Fintepla is a new treatment option that in clinical studies provided significant, well-tolerated, and lasting seizure reduction to many Dravet syndrome study patients. In 2020, FINTEPLA (fenfluramine) oral solution was approved by the
About Dravet Syndrome
Dravet syndrome is a rare, devastating and life-long form of epilepsy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of sudden unexpected death in epilepsy (SUDEP). Affecting one in 15,700 live births in the
Durbin is a specialist pharmaceutical services provider, distributing critical medications to over 160 different countries. A part of Uniphar Group’s Product Access Division, Durbin works in partnership with global pharmaceutical and biotech companies to provide Early Access Programs (EAPs), including Named Patient Supply and Cohort Programs. The company has over 25 years’ experience designing and implementing EAPs from concept and specializes in developing robust and compliant voluntary data collection initiatives that run seamlessly alongside the programs they manage.
Forward Looking Statements
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 timing of the availability of FINTEPLA through the Zogenix Access Program; and Zogenix’s expectations on the submission of a J-NDA by Nippon Shinyaku in
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Source: Zogenix, Inc