GW Pharma gets Orphan Drug Designation From Print E-mail
By Marilyn Mullen   
Friday, 24 April 2015 14:24


GW Pharmaceuticals PLC - ADR (NASDAQ:GWPH) has confirmed that U.S. Food and Drug Administration has given orphan drug designation to the Cannabidiol (CBD) for using in treatment of newborn children having neonatal hypoxic-ischemic encephalopathy (NHIE).

NHIE is an acute brain injury because of asphyxia during birth process as well as deprivation of oxygen during birth (hypoxia).

NHIE incidence is 1.5 to 2.8 per 1,000 births in United States.  This means on an average 6,500 to 12,000 cases per year.

From this number, over 35% may die early and more than 30% may suffer from permanent disability. Presently, there are no FDA-approved medicines specifically for NHIE.

The firm has made an intravenous CBD formulation for using in the patient population. It had a pre-IND meeting with FDA and anticipates submission of Investigational New Drug Application (IND) in mid-2015 along with starting Phase 1 trial in second half of 2015.

GW is also doing pre-clinical research into neuroprotective effects of CBD in animal models since 2008. Research demonstrates that CBD lowers neurologic disability across a number of newborn animal models of brain hypoxia.

Justin Gover, GW's Chief Executive Officer, opined that GW is exploring opportunity for developing cannabinoids in rare pediatric conditions characterized by significant unmet need. He added that the orphan drug designation for cannabidiol for treating of newborn children with neonatal hypoxic-ischemic encephalopathy is a result of several years of pre-clinical evaluation and the firm is looking forward in advancing clinical development program in this essential medical condition later this year.

Shares of the company jumped 1.47% to $122.55 and made a new 52-week high of $122.82 earlier in the session.

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