US FDA grants Fast Track designation for GW Pharma's Epidiolex in Dravet syndrome

The US Food and Drug Administration has granted Fast Track designation to UK-based GW Pharmaceuticals’ (Nasdaq: GWPH) investigational cannabidiol (CBD) product, Epidiolex, in the treatment of Dravet syndrome, a treatment-resistant form of childhood epilepsy.

The FDA’s Fast Track program facilitates the development and review of drugs intended to treat serious conditions and fill an unmet medical need. Justin Gover, GW’s chief executive, said: “GW is focused on advancing the Epidiolex development program as rapidly as possible with the aim of addressing the significant unmet need in children suffering from Dravet syndrome. The granting of Fast Track designation, in addition to Epidiolex having already received orphan drug designation from the FDA, represents significant additional support toward this objective. With GW having already opened an Investigational New Drug (IND) for Epidiolex, we are on track to commence a Phase II/III clinical trial in Dravet syndrome in the second half of this year.”

In addition to Dravet syndrome, GW plans to conduct a clinical development program for Epidiolex in the treatment of Lennox-Gastaut syndrome (LGS). Following receipt earlier this year of orphan drug designation by the FDA in LGS, GW expects to hold a pre-IND meeting with the FDA for Epidiolex in the treatment of LGS in mid-2014, and expects to conduct two Phase III trials in LGS during 2015.