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Zogenix Announces New Efficacy and Safety Data on ZX008 for Treatment of Seizures in Dravet Syndrome

Patient and Caregiver Sleep Quality and Quality of Life Data Reported for First Time

New Clinical Data Presented at 14th International Child Neurology Congress on the Use of Low-Dose Fenfluramine in Managing Seizures Associated With Dravet Syndrome

EMERYVILLE, Calif., May 05, 2016 (GLOBE NEWSWIRE) -- Zogenix, Inc. ZGNX, -3.60% a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, today announced new data which continues to demonstrate the sustained effectiveness and cardiovascular safety of ZX008 (low-dose fenfluramine) as an adjunctive therapy for seizures associated with Dravet syndrome. In addition, for the first time, data were presented on patient and caregiver sleep quality and quality of life. The podium presentation was given at the 14 [th] International Child Neurology Congress (ICNC), taking place this week in Amsterdam, The Netherlands. ZX008 is designated as an orphan drug in both the U.S. and Europe, and recently received Fast Track designation in the U.S., for the treatment of Dravet syndrome.

The data presented highlighted the updated results from the new patient cohort, which now includes 9 Dravet syndrome patients. All of these patients began add-on treatment with low-dose fenfluramine (5 mg to 20 mg per day) at various starting points between 2010 and the end of January 2016. Median treatment duration was 1.5 years (range 0.3 to 5.1 years). During the 90-day run-in period prior to initiating low-dose fenfluramine treatment, the median frequency of major motor seizures (defined as tonic, clonic, tonic-clonic, atonic, and myoclonic seizures lasting >30 seconds) was 15.0 per month (range 0.4 to 39.7). Over the entire observation period, the median frequency of major motor seizures was reduced to 1.5 per month, and the median decrease was 75% (range 28-100%). Six of the 9 patients had at least a 70% reduction in major motor seizures.

In addition, parents/caregivers were asked to rate both their child's and their own sleep quality and quality of life using 0-10 scales where 0 = extremely bad and 10 = very good. At the most recent visit, mean sleep quality reported for patients and parents was 8.1/10 and 7.9/10, respectively, while...


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