GW Pharmaceuticals' Epidiolex granted FDA fast track status for Dravet syndrome

GW Pharmaceuticals announced Friday that the experimental cannabidiol therapy Epidiolex received fast track status from the FDA for the treatment of Dravet syndrome. CEO Justin Gover remarked that the drugmaker "is focused on advancing the Epidiolex development programme as rapidly as possible with the aim of addressing the significant unmet need in children suffering from Dravet syndrome."

Gover said that the company plans to start a Phase II/III study of Epidiolex in the second half of 2014. Epidiolex is currently being used by seven paediatric epilepsy specialists in the US under the FDA's expanded access programme initiated after the therapy was granted orphan drug status by the agency last year.

GW Pharmaceuticals added that it will also conduct a clinical development programme for Epidiolex for the treatment of Lennox-Gastaut syndrome after the compound received orphan drug status from the FDA for the indication in February. The company said that it plans to meet with the FDA regarding this indication in mid-2014 and expects to conduct two Phase III studies next year.

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