GW Pharmaceuticals has been boosted by the news that the US Food and Drug Administration has granted fast-track designation to the UK firm’s investigational cannabidiol Epidiolex, in the treatment of Dravet syndrome.
The company noted that Dravet is “a rare and catastrophic treatment-resistant form of childhood epilepsy. The syndrome, also known as severe myoclonic epilepsy of infancy (SMEI), sees seizures begin in the first year of life, and is “remarkably resistant to medical therapy”. Individuals with Dravet syndrome face a higher incidence of sudden unexplained death in epilepsy and have associated co-morbid conditions.
GW chief executive Justin Gover said that the granting of fast-track status, in addition to Epidiolex having already received orphan drug designation from the FDA, “represents significant additional support” for the drug. He added that the firm is on track to commence a Phase II/III trial in Dravet in the second half of this year.
GW is also developing Epidiolex in the treatment of Lennox-Gastaut syndrome and expects to conduct two Phase III trials in during 2015.