The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the New Drug Application (NDA) for Fintepla (low-dose fenfluramine oral solution; Zogenix) for the treatment for seizures associated with Dravet syndrome.
An amphetamine derivative, fenfluramine was initially developed as an appetite suppressant that is believed to work through serotonergic mechanisms. In the 1990s, the drug was withdrawn by the FDA due to cardiovascular safety concerns, however it continues to be investigated for other therapeutic uses.
The NDA includes data from two phase 3 trials and also interim analysis from an ongoing open-label extension study involving 232 patients with Dravet syndrome. Results from these trials showed that the treatment substantially reduced monthly convulsive seizure frequency and was not associated with cardiovascular toxicity.
The Agency has set a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2020 for Fintepla.
A phase 3 trial evaluating Fintepla in Lennox-Gastaut syndrome is currently ongoing. The Company expects topline results from this trial during the first quarter of 2020.
For more information visit zogenix.com.