Washington, D.C. — An advisory committee for the Food and Drug Administration (FDA) on Thursday recommended approval of the first pharmaceutical grade cannabidiol (CBD) medicine to treat severe epilepsy. In a unanimous decision, the committee voted to recommend GW Pharmaceuticals drug Epidiolex for approval.
Cannabidiol, commonly referred to as CBD, is a non-psychoactive cannabis derivative. The approval of Epidiolex would be limited to treating seizures in patients aged 2 and older caused by Lennox-Gastaut syndrome and Dravet syndrome.
“Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death,” said Philip Gattone, president and CEO of the Epilepsy Foundation.
Taking a natural product such as CBD oil and turning it into a FDA approved drug has the potential to limit the avenues that people have to access the natural product. Motherboard reported last year on the drug industry lobbying for legislation that would outlaw CBD oil by turning it into a drug. South Dakota Senate Bill 95 had sought to exempt CBD from the definition of cannabis, thus taking it off Schedule I controlled substance list and becoming a Schedule IV substance.
GW Pharmaceuticals and its U.S. subsidiary, Greenwich BioSciences, lobbied for an amendment to the legislation to limit CBD rescheduling to only FDA-approved products— in other words, they wanted only CBD drugs to be legally obtainable.
A 2017 report from Motherboard explained:
Not surprisingly, GW Pharmaceuticals has just such a drug in the pipeline. Epidiolex, a ‘proprietary oral solution of pure plant-derived cannabidiol,’ has already been given to epileptic children in the U.S. as part of a federal investigative study documented recently in the New England Journal of Medicine.”