The director of the Pediatric Epilepsy Center at UCSF Benioff Children’s Hospital discussed the efficacy profile of ZX008, for which Zogenix recently submitted a new drug application to the FDA for the treatment of Dravet syndrome.
“The efficacy speaks for itself, all of these drugs are going to have a side effect profile, but the side effect profile that we saw in the phase 3 programs and that has been confirmed in the open-label extension has shown that it’s a safe and well-tolerated drug.”
Zogenix recently submitted a new drug application (NDA) to the FDA for ZX008 (Fintepla), its investigational low-dose fenfluramine agent for the treatment of seizures associated with Dravet syndrome. The NDA is based by data from 2 phase 3 trials and interim data from the ongoing open-label extension study.
At the American Epilepsy Society’s 2018 annual meeting in New Orleans, Louisiana, Joseph Sullivan MD, director of the Pediatric Epilepsy Center at UCSF’s Benioff Children’s Hospital and an investigator in ZX008’s clinical development program, sat down with NeurologyLive in an interview to discuss the treatment’s efficacy profile.
Sullivan explains that the efficacy speaks for itself and that while every agent will have a side effect profile, overall, ZX008 has been shown to be a safe and well-tolerated drug.