The findings were shared at the 2020 American Epilepsy Society (AES) Annual Meeting, in the presentation, “Treatment with Fintepla (fenluramine) in Patients with Dravet Syndrome Has No Long-term Effect on Weight and Growth.”
Fintepla (formerly ZX008) is an oral anti-seizure treatment for Dravet syndrome developed by Zogenix. The medication has been approved to treat Dravet syndrome patients 2 and older in the U.S. and in Europe.
These regulatory approvals were based on positive data from two identically designed Phase 3 clinical studies, ZX008-1501 (NCT02682927) and ZX008-1502 (NCT02826863), as well as interim findings from an open-label extension study (NCT02823145), that is evaluating the long-term effectiveness and safety of Fintepla in participants who completed either the ZX008-1501 or ZX008-1502 Phase 3 studies.
The ZX008-1502 Phase 3 trial is still recruiting in Europe, Japan, and Australia; more information about locations is available here.
The active component in Fintepla is fenfluramine (FFA). One of the known effects of this medication is weight decrease, and appetite disturbances are common in people with Dravet. How and whether Fintepla treatment affects growth and weight gain in children with Dravet has not been clear.
At the AES meeting, researchers from Zogenix and colleagues presented new data from the open-label trial. Participants were given a low 0.2 mg/kg/day starting dose of FFA, which was tailored based on efficacy in each participant to a final dose of 0.2-0.7 mg/kg/day.
At the time of the analysis, a total of 279 trial participants had been treated with Fintepla for at least a year, and 128 participants had been treated for at least two years.
Statistical analyses comparing growth rates at the start of the study and after one or two years showed no substantial impact on either height or weight. These analyses accounted for height, weight, age, sex, body surface area, and body mass index.
“Long-term treatment with Fintepla had minimal impact on DS [Dravet syndrome] patients’ growth,” the researchers wrote.
“We are honored to collaborate with leading international epilepsy experts to broaden our understanding of how Fintepla, a drug recently approved by the FDA to treat seizures associated with Dravet syndrome, may improve the lives of epilepsy patients and their families,” Bradley S. Galer, MD, chief medical officer at Zogenix, said in a press release.
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