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GW Pharmaceuticals Receives Orphan Drug Designation from FDA

Submitted by Marijuana News on Mon, 04/27/2015 - 08:00

London, UK; 24 April 2015: GW Pharmaceuticals plc (AIM: GWP, Nasdaq: GWPH, "GW") announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Cannabidiol (CBD) for use in treating newborn children with neonatal hypoxic-ischemic encephalopathy (NHIE). NHIE is acute or sub-acute brain injury due to asphyxia caused during the birth process and resulting from deprivation of oxygen during birth (hypoxia).

The incidence of NHIE is 1.5 to 2.8 per 1,000 births in the United States, or, 6,500 to 12,000 cases per year. Of these, 35% are expected to die in early life and 30% may suffer from permanent disability. There are currently no FDA-approved medicines specifically indicated for NHIE.

GW has developed an intravenous CBD 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 (IND) in mid-2015 and to...

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http://www.gwpharm.com/

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