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June 6, 2014
05:19 EDTGWPHGW Pharmaceuticals receives Fast Track designation for Epidiolex
GW Pharmaceuticals announced that the 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. In addition to Dravet syndrome, GW plans to conduct a clinical development program for Epidiolex in the treatment of Lennox-Gastaut syndrome. 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.
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