The FDA gives GW Pharmaceuticals (GWPH) the green light to commence its Phase 2/3 clinical trial for Epidiolex, its orphan drug-designated treatment for Dravet Syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. The trial should start in 2H 2014.
The first part of the study will dose 30 patients over a three-week time frame to evaluate the drug's pharmacokinetics and clarify the appropriate dosing parameters. The second part will be a placebo-controlled evaluation of Epidiolex for safety and efficacy in 80 patients over three months. The Phase 3 trial should commence in Q1 2015.