GW Pharmaceuticals announced that the FDA has granted Orphan Drug designation to Epidiolex for the use in treating children with Dravet syndrome, a rare and severe form of form of infantile-onset, genetic, drug-resistant epilepsy syndrome.
Epidiolex is an oral liquid formulation of a highly purified extract of plant-derived Cannabidiol (CBD), a non-psychoactive molecule from the cannabis plant.
GW’s clinical development program for Epidiolex in Dravet syndrome is expected to commence in 2014. In addition, GW has arranged to enable independent U.S. pediatric epilepsy specialists to treat high need pediatric epilepsy cases with Epidiolex immediately. To date in 2013, a total of seven “expanded access” INDs have been granted by the FDA to U.S. clinicians to allow treatment with Epidiolex of approximately 125 children with epilepsy.
For more information call (917) 280-2424 or visit GWPharm.com.