Zogenix PR: Topline Ph3 FINTEPLA in LGS

February 7, 2020
Zogenix Announces Positive Top-line Results from Global Pivotal Phase 3 Trial of FINTEPLA® for the Treatment of Lennox-Gastaut Syndrome 

  • Primary Endpoint Achieved – Statistically Significant Reduction in Drop Seizures for FINTEPLA 0.7 mg/kg/day versus Placebo 
  • FINTEPLA Also Demonstrated Statistically Significant Improvement on Multiple Secondary Endpoints 
  • Zogenix to Host Conference Call and Live Webcast Today at 4:30 PM Eastern Time/1:30 PM Pacific Time 

EMERYVILLE, California, February 6, 2020 – Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today reported positive top-line results from its global Phase 3 clinical trial (Study 1601) of its lead investigational therapy, FINTEPLA® (ZX008, fenfluramine oral solution) in Lennox- Gastaut Syndrome (LGS), a severe and treatment-resistant childhood-onset epilepsy. The trial met its primary objective of demonstrating that FINTEPLA at a dose of 0.7 mg/kg/day was superior to placebo in reducing the frequency of drop seizures, based on the change between baseline and the titration and maintenance treatment period (p=0.0012). The same dose of FINTEPLA (0.7 mg/kg/day) also demonstrated statistically significant improvements versus placebo in key secondary efficacy measures, including the proportion of patients with a clinically meaningful reduction (≥50%) in drop seizure frequency. A decrease in the frequency of drop seizures between baseline and the treatment period was observed for a lower dose of FINT