GW Pharmaceuticals Receives Orphan Drug Designation From FDA for Cannabidiol for the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy

Industry News

GW Pharmaceuticals (based in Research Triangle Park, NC) announced that it has received Orphan Drug Designation from the FDA for Cannabidiol (CBD) for the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE).  NHIE is acute or sub-acute brain injury due to asphyxia.   The primary cause of this condition is systemic deprivation of oxygen during birth.  NHIE can lead to death or permanent disability depending on the severity.  This particular CBD is GWP42003 in the company’s pipeline and it has been developed into an intravenous formulation for newborn patients.  Preclinical studies conducted by the company have shown that CBD reduces neurologic disability across a range of newborn animal models of brain hypoxia.  The company is planning to file an IND in mid-2015.


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