EMERYVILLE - Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that The Lancet has published the results of its Phase 3 clinical trial, Study 1, of the Company's investigational drug, FINTEPLA (ZX008, fenfluramine oral solution), in children and young adults with Dravet syndrome, a rare, severe infantile-onset epilepsy characterized by frequent, disabling seizures that are very difficult to treat with existing anti-epileptic drugs.

The study showed that both doses of FINTEPLA, when added to the patients' existing treatment regimens, provided a significant reduction in convulsive seizure frequency compared to placebo.

'The results from this study are tremendously encouraging in reducing the magnitude and duration of seizures in our patients with Dravet syndrome,' said Joseph Sullivan, M.D., Director of the Pediatric Epilepsy Center of Excellence at the UCSF Benioff Children's Hospitals, co-lead author of the manuscript, and Principal Investigator for Study 1. 'If future outcomes are as positive, it could help clinicians set new standards of care for a treatment-resistant disease like Dravet syndrome, in which frequent debilitating seizures and significant cognitive and functional impairments are the norm.'

Study 1 was an international, double blind, placebo-controlled Phase 3 study of 119 Dravet syndrome patients ages 2-18 years (mean age 9 years) treated at sites in the U.S., Canada, Europe and Australia. Patients were randomized to one of three treatment groups: FINTEPLA at 0.7 mg/kg/day with a 26 mg maximum daily dose (n=40), FINTEPLA at 0.2 mg/kg/day (n=39), or placebo (n=40), which were added to the patient's current antiepileptic drug regimen that excluded use of stiripentol. Following a 6-week baseline observation period, patients were titrated to their target dose over two weeks and remained at that dose for 12 weeks. The mean baseline convulsive seizure frequency across the study groups was approximately 40 seizures per month.

The primary endpoint was the change in mean monthly frequency of convulsive seizures during the treatment period compared with baseline in the 0.7 mg/kg/day group versus placebo. Results showed that patients taking FINTEPLA at 0.7 mg/kg/day achieved a 62.3% greater reduction in mean monthly convulsive seizure frequency compared to placebo (95% CI -47.7 to -72.8, p

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