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GW Pharmaceuticals’ CBD plant extract Epidiolex has been granted “Orphan Drug” status by the Food and Drug Administration, setting the stage for Phase 2 clinical trials later this year. The Realm of Caring Foundation, a Colorado-based non-profit, is also making CBD-rich plant extracts available to the parents of pediatric epilepsy patients. And other entities have begun producing and distributing CBD medicaments. GW will not have a monopoly—but it will have the edge with physicians who would rather prescribe an FDA-approved medication than recommend an extract available at the local dispensary.
Here’s GW’s press release, datelined London, Feb. 28, 2014:
GW Pharmaceuticals Receives Orphan Drug Designation by FDA for Epidiolex® in the Treatment of Lennox-Gastaut Syndrome
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 Epidiolex®, GW’s product candidate that contains plant-derived Cannabidiol (CBD) as its active ingredient, for use in treating children with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. Epidiolex is an oral liquid formulation of a highly purified extract of CBD, a non-psychoactive molecule from the cannabis plant.
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