FDA Grants “Orphan Drug” Status to GW’s Epidolex

Epidolex GW Pharmaceutical
By on March 03, 2014

Published in full on BeyondTHC.com.

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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