GW Pharma initiates Phase 3 study of Epidiolex in Dravet syndrome
GW Pharmaceuticals (NASDAQ:GWPH) commences the Phase 3 segment of a Phase 2/3 clinical trial evaluating Epidiolex (cannabidiol) for the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. Top-line data are expected by the end of the year.
The first part of the study, the Phase 2, determined the pharmacokinetics and dose of Epidiolex in 34 patients over a three-week period. It was completed in February. The dose for the Phase 3 will be 20 mg/kg.
The 14-week Phase 3 trial will assess Epidiolex versus placebo in 100 patients as an adjunctive antiepileptic treatment. The primary efficacy endpoint is the percent change from baseline in convulsive seizure frequency during the maintenance period of the study compared to placebo. All patients will be newly recruited, with none from the Phase 2 portion.
The company forecasts that it will submit a New Drug Application (NDA) for Orphan Drug- and Fast Track-designated Epidiolex for Dravet syndrome to the FDA in mid-2016
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