Zogenix Presents New Data for FINTEPLA in Dravet Syndrome at CNS 2020

• Interim data from open-label extension trial showed substantial seizure reductions were maintained in patients treated with FINTEPLA for up to two years

• Post-hoc analysis demonstrated NNTs (Number Needed to Treat) to achieve a clinically meaningful response compared favorably to similar studies of other Dravet syndrome therapies

EMERYVILLE, Calif., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq: ZGNX), a global biopharmaceutical company developing rare disease therapies, shared new data analyses for FINTEPLA (fenfluramine) oral solution in Dravet syndrome at the Child Neurology Society and International Child Neurology Congress (CNS/ICNA) 2020. Dravet syndrome is a rare, highly refractory form of infant- and childhood-onset epilepsy marked by frequent and often prolonged seizures that are difficult to control with existing medications, significant cognitive and motor impairments, and a higher risk of sudden death.

“In addition to the significant convulsive seizure reductions seen in all three multi-national Phase 3 studies of FINTEPLA in Dravet syndrome, we are proud to collaborate with expert clinician investigators to show the durability of the clinically meaningful seizure reduction that FINTEPLA provided for patients treated for up to two years,” said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer at Zogenix. “Furthermore, new post-hoc data analysis from our studies demonstrated that for every two to three patients treated with FINTEPLA, one patient achieved ≥75% (profound) convulsive seizure reduction compared with placebo. We believe these new data analyses further showcase the clinical value that FINTEPLA provides for many Dravet syndrome patients and their families.”

The company’s CNS 2020 posters are now available in the Zogenix Newsroom and include:

• Long-Term (2-Year) Safety and Efficacy of Adjunctive ZX008 (Fenfluramine HCl) for Dravet Syndrome: Interim Results of an Ongoing Open-Label Extension Study
  (Sullivan, Auvin, Pringsheim et al)
  
  
• Number Needed to Treat (NNT) with Fenfluramine to Achieve a Clinically Meaningful Reduction in Convulsive Seizure Frequency in Patients with Dravet Syndrome
  (Sullivan, Dlugos, Nabbout et al)
  
  
• Quantifying “Clinically Meaningful Changes” in Seizure Frequency—Data From 3 Phase 3 Studies of ZX008 (Fenfluramine Hydrochloride Oral Solution) in Dravet Syndrome: Do Expectations and Views Change Over Time?