GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to GW’s investigational cannabidiol product, Epidiolex, in the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.

“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,” stated Justin Gover, GW’s Chief Executive Officer. “With GW having already opened an Investigational New Drug (IND) for Epidiolex, we are on track to commence a Phase 2/3 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 in 2014 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 3 trials in LGS during 2015.

For more details, go to: http://www.gwpharm.com/GW%20Pharmaceuticals%20Announces%20Epidiolex%20Receives%20Fast%20Track%20Designation%20from%20FDA%20for%20the%20Treatment%20of%20Dravet%20Syndrome.aspx