Zogenix announced that detailed results of the Phase 2, open-label study evaluating its investigational drug, ZX008, for the treatment of refractory patients with Lennox-Gastaut Syndrome, or LGS, were published in the September issue of Epilepsia. Consistent with the previously-reported data from this study, the results demonstrated that ZX008 provided sustained, clinically meaningful seizure reduction in the majority of patients and was generally well-tolerated. The single-center, Phase 2, open-label dose-finding trial was a 20-week core study and a long-term extension option for those patients who were responders in the core study. Results presented in the paper included up to 15 months of treatment for patients in the long-term extension. Patients initiated treatment of ZX008 twice-daily. Patients who were responders remained at their effective dose, while non-responders were considered for a dose increase. Patients enrolled in the study had refractory LGS and a baseline median seizure frequency of 61 per month with multiple seizure types. Patients failed a median of five anti-epileptic treatments, including vagus nerve stimulation and ketogenic diet. Patients achieved a 53% median reduction in convulsive seizure frequency during the 20-week treatment period of the core study. A reduction in convulsive seizure frequency of at least 50% was seen in 62% of patients, with a reduction of at least 75% being reported in 23% of patients. The median dose of ZX008 was 0.4 mg/kg/day.
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