GW Pharmaceuticals (NASDAQ:GWPH) edges up 3% premarket on light volume in response to its announcement that it has formalized a fourth target indication, infantile spasms (IS), for lead product candidate Epidiolex (cannabidiol). The FDA has designated Epidiolex an Orphan Drug for the treatment of IS. A two-part Phase 3 study should commence in Q4.
IS is an epilepsy-type of seizure in infancy and childhood known as West syndrome. The condition constitutes 2% of childhood epilepsy cases. It affects 2K – 4K American kids each year. The long-term prognosis is poor.
Epidiolex is currently under development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex.