GW Pharma Receives Orphan Drug Status For Cannabidiol In NHIE; Stock UP

(RTTNews) - GW Pharmaceuticals Plc. (GWPH, GW.L) Friday said the U.S. Food and Drug Administration has granted orphan drug designation for Cannabidiol for use in treating newborn children with neonatal hypoxic-ischemic encephalopathy or NHIE, an acute or sub-acute brain injury due to asphyxia caused during the birth process as a result of deprivation of oxygen during birth.

The incidence of NHIE is 1.5 to 2.8 per 1,000 births in the U.S., or, 6,500 to 12,000 cases per year. Of these, 35 percent are expected to die in early life and 30 percent may suffer from permanent disability. There are currently no FDA-approved medicines specifically indicated for NHIE. GW has developed an intravenous Cannabidiol formulation for use in this patient population. GW held a pre-IND meeting with the FDA and expects to submit an Investigational New Drug Application in the middle of 2015 and to commence a Phase 1 trial in the second half of 2015.

The stock added 3.2 percent to 660.00 pence.