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Fly News Breaks for December 5, 2016
ZGNX
Dec 5, 2016 | 08:11 EDT
Zogenix announced new data demonstrating effectiveness and cardiovascular-related safety for patients treated with ZX008 as an adjunctive therapy for seizures associated with Lennox Gastaut Syndrome, or LGS, and continued effectiveness and safety for the on-going open-label patients with Dravet syndrome. The data were presented at the 70th Annual American Epilepsy Society meeting, taking place this week in Houston, Texas. The LGS data presented were from an interim analysis of the first 13 patients to have completed at least 12 weeks of a Phase 2 open-label, dose-finding investigator-initiated study, led by Lieven Lagae, M.D., Ph.D., Professor at the University of Leuven, Belgium, Head of the Pediatric Neurology Department and Director of the Childhood Epilepsy Program at the University of Leuven Hospitals. Patients enrolled in the study were 3-18 years of age diagnosed with LGS with at least four convulsive seizures and on at least two anti-epileptic drugs, or AEDs, at stable doses in the four weeks prior to study initiation. Participants were treated with ZX008 as an add-on therapy for up to 20 weeks starting at 0.2mg/kg/day. The dose could be titrated at four-week intervals based on treatment response up to a maximum of 0.8 mg/kg/day if the patient did not reach at least a 50% reduction in major motor seizure frequency. It is important to note that, per protocol, dose escalation stopped when a patient's major motor seizure frequency was reduced by greater than or equal to 50% of baseline. The mean age of participants was 11.4 years and they had failed a median of five antiepileptic therapies prior to this study. At study initiation, patients were receiving a median of four antiepileptic therapies. The median number of major motor seizures during the four-week baseline period was 60. In the Intent-to-Treat, or ITT, patient population, there was a median 50% reduction in seizure frequency over the entire treatment period compared to baseline, with seven patients to date achieving a greater than or equal to 50% reduction in the number of major motor seizures in this step dose study.
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