On June 25th, 2020, the FDA announced approval of FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. In two Phase 3 placebo-controlled clinical trials FINTEPLA demonstrated significant reductions in convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications. Separately, the company has a late stage development program for FINTEPLA underway for treatment of seizures associated with Lennox-Gastaut syndrome.
FINTEPLA labeling includes a boxed warning stating that there is an association between serotonergic drugs with 5‑HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Because of these risks, patients must have cardiac monitoring using echocardiograms performed before treatment, every six months during treatment, and once three to six months after treatment is discontinued. If the echocardiogram shows signs of VHD, PAH, or other cardiac abnormalities, health care professionals must consider the benefits and risks of continuing treatment with FINTEPLA for the patient.
FINTEPLA will be available to patients through certified prescribers via a restricted distribution program, called the FINTEPLA Risk Evaluation and Mitigation (REMS) Program, and is expected to be available through Zogenix’s specialty pharmacy partner by the end of July 2020. The FINTEPLA REMS Program requires health care professionals who prescribe FINTEPLA and pharmacies that dispense FINTEPLA to be specially certified in the FINTEPLA REMS Program and that patients be enrolled in the REMS Program. As part of the REMS Program requirements, prescribers and patients must adhere to the required cardiac monitoring with echocardiograms to receive FINTEPLA.
Zogenix is also launching Zogenix Central™, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information will be available at www.FINTEPLA.com to assist patients and their families. Interested patient families should speak with their healthcare provider to discuss whether this treatment is appropriate for their loved one.
Thank you to all of the patient families who participated in the trials that led to approval of FINTEPLA, the clinicians who oversaw the studies, and the team at Zogenix for their dedication in bringing this product to market. We are pleased to see another treatment option available for the Dravet syndrome patient community.
The full press release from the FDA is available at this link.
The full press release from Zogenix is available at this link.