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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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How often have we heard, “More research is needed,” from those who would prefer to see no change in policies that should be informed by science? From climate denial to cannabis prohibition, the demand for absolute scientific certainty is a call for inaction. It begs the question: When is there “enough” research? How about not enough to eliminate all uncertainties, but enough to recommend medical treatment or change policy?
Cannabis and its derivatives have been documented for anti-epileptic effects since 1881. Today, the promise of cannabidiol (CBD) as an anti-epileptic treatment is prompting people to move to states that have safe access to medicinal products containing this compound.
A third of patients still do not find effective methods for preventing seizures. A recent Canadian study has demonstrated synergy between the anti-seizure activity of THC and CBD.
Cannabidiol (CBD) is an astonishingly safe drug. Currently, the biggest safety concern is that at high doses it can alter the metabolism of other pharmaceuticals. That means CBD might amplify the toxicity of other drugs. This has come to a fore with epilepsy treatment, since overdosing anti-epileptic drugs (AEDs) is very dangerous.