As you may have already heard, yesterday, FDA gave its highly anticipated approval to Greenwich Biosciences, a subsidiary of England's GW Pharmaceuticals, for Epidiolex, a purified cannibidiol (CBD) extract derived from the cannabis plant (cannabis sativa). It is the first FDA-approved drug that contains a purified drug substance derived from cannabis.
The approval covers two rare forms of epilepsy that previously had no viable remedies. The approval does not change DEA's listing of cannabis as a Schedule 1 drug, nor does it clarify the role of CBD as a possible dietary supplement, which FDA currently says is illegal. We hope that this action sets in motion a sensible, science-based process that leads to a federal standard allowing for the sale of CBD products that fall under the umbrella of the Dietary Supplement Health and Education Act.
UNPA is in the formative stages of creating a hemp oil/CBD committee to address the regulatory and many other issues surrounding the non-psychoactive components of cannabis and will begin its work this summer, including a proposed conference call/webinar with a representative of GW Pharma to discuss the company's plans for Epidiolex and how it fits into the broader potential market for CBD products.
Below is FDA's press release announcing the Epidiolex appproval.
Attached is GW's press release announcing the approval.
Also see FDA Commissioner Scott Gottlieb's comments on the importance of research to prove safe and effective medical uses for the active constituents in cannabis.
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated withtwo rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the firstFDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatmentof patients with Dravet syndrome.
Continue reading...U.S. Food and Drug Administration
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