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
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
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 mean Quality of Life scores were 7.4/10 for both groups.
In this new cohort of patients, treatment with low-dose fenfluramine continued to be generally well-tolerated, and did not result in any echocardiographic or clinical signs of cardiac valve abnormalities, pulmonary hypertension or any other cardiovascular abnormalities. The most common treatment-emergent adverse events were mild-to-moderate somnolence (n=6), diminished appetite (n=4), mood changes (n=2), and non-convulsive status epilepticus (n=2). There were no fenfluramine discontinuations due to adverse events or lack of effect.
“The continued meaningful reduction in seizure frequency and sustained cardiovascular safety demonstrated in these updated results for the new cohort of patients further support our confidence in the potential of ZX008 as a safe and effective treatment for seizures associated with Dravet syndrome,” said
The observed effectiveness, tolerability and cardiovascular-related safety with add-on, low-dose fenfluramine in this new cohort of Dravet syndrome patients further extends the findings initially reported for the original twelve subjects in 2012 and the initial report from this new cohort in December of 2015.
About the ZX008 Phase 3 Program
For more information, visit www.zogenix.com.
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Andrew McDonaldFounding Partner, LifeSci Advisors LLC646-597-6987 | Andrew@lifesciadvisors.com