The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for fenfluramine, for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).
An amphetamine derivative, fenfluramine was initially developed as an appetite suppressant and is believed to work through serotonergic mechanisms. The sNDA submission is supported by data from a global randomized, placebo-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT03355209) that compared the efficacy and safety of fenfluramine with placebo in 263 patients aged 2 to 35 years with LGS.
Findings showed that treatment with fenfluramine 0.7mg/kg/day met the primary endpoint demonstrating superior reductions in the frequency of drop seizures compared with placebo (P =.0012). A statistically significant improvement in the proportion of patients with a clinically meaningful reduction (50% or greater) in drop seizure frequency (secondary efficacy endpoint) was also observed with fenfluramine.
The sNDA also includes long-term safety and efficacy data from ongoing open-label extension trials. The safety profile of fenfluramine was found to be consistent with that observed in previous studies for Dravet syndrome.
A Prescription Drug User Fee Act (PDUFA) target date of March 25, 2022 has been set for the application.
Fenfluramine, a schedule IV controlled substance, is currently marketed under the brand name Fintepla® and is approved for the treatment of seizures associated with Dravet syndrome. The product is available as a cherry-flavored oral solution containing 2.2mg/mL of fenfluramine.
- Zogenix announces US FDA acceptance for Priority Review of supplemental New Drug Application for Fintepla® (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS). News release. Zogenix, Inc. Accessed December 1, 2021. https://www.globenewswire.com/news-release/2021/12/01/2344064/0/en/Zogenix-Announces-U-S-FDA-Acceptance-for-Priority-Review-of-Supplemental-New-Drug-Application-for-FINTEPLA-Fenfluramine-for-the-Treatment-of-Seizures-Associated-with-Lennox-Gastaut.html.
- Zogenix submits supplemental New Drug Application for Fintepla® (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome. News release. Zogenix, Inc. September 28, 2021. Accessed December 1, 2021. https://zogenixinc.gcs-web.com/news-releases/news-release-details/zogenix-submits-supplemental-new-drug-application-finteplar.