On June 26, 2020, the Food and Drug Administration (FDA) approved a new drug application (NDA) for Fintepla (fenfluramine; Zogenix Inc.), an oral selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
Fenfluramine was originally developed for the management of exogenous obesity as a short-term adjunct in a regimen of weight reduction and sold under the brand name Pondimin; it was withdrawn from the U.S. market in 1997 following the occurrence of cardiac valvulopathy and pulmonary arterial hypertension in some individuals. The current FDA approval was supported by data from 2 clinical studies in 202 participants, which demonstrated that participants treated with Fintepla had significantly greater reductions in the frequency of convulsive seizures compared with placebo. These reductions were seen within 3 to 4 weeks and remained generally consistent over the 14- to 15-week treatment period.
The Fintepla label carries a boxed warning regarding risk of valvular heart disease and pulmonary arterial hypertension. The FDA recommends that patients have echocardiography monitoring before treatment, every 6 months during treatment, and once 3 to 6 months after treatment is discontinued.
Food and Drug Administration (FDA). FDA Approves New Therapy for Dravet Syndrome [news release]. June 25, 2020. Available at: click here. Accessed June 29, 2020.