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.”
“Since no other pharmaceutical company has a CBD drug anywhere close to market, and the wide range of CBD products already available in medical marijuana states lack FDA approval, if the bill had passed with that amendment intact, patients in South Dakota would have been subjected to a virtual CBD monopoly …
More ominously, The Great CBD Battle of South Dakota appears to be but the opening salvo in a nationwide war between GW Pharmaceuticals and traditional medical cannabis providers …
[U]nder the amendment, South Dakota would … ban myriad CBD products already available in many other states. Even though they cost far less than Epidiolex, and are potentially more effective for patients, since in addition to CBD those ‘full spectrum’ cannabis extracts also contain small amounts of THC and other medicinal components of the plant.
Motherboard also noted that “corporate lobbyists in more than 20 states are currently pushing to make sure the pharmaceutical industry has the only legal supply of CBD.” Thus, it appears the big pharma takeover of CBD is underway.
“It’s incredibly important as a physician prescribing to patients that we know what we’re giving them and we know we give them one month will be the same that we give them three or six months later,” said Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center, attempting to explain the importance of pharmaceutical intervention in the CBD market.
“It’s very important to highlight that the drug used in this study, cannabidiol, was derived from cannabis plants, and purified to 99 percent purity,” Devinsky told NBC News. “This is not something you can get from a dispensary today in the United States. It’s not something that you can get by smoking marijuana. It is a very specific pharmaceutical grade product derived from marijuana, but quite different than what is available anywhere else right now in the United States.”
NBC News reported that the FDA has indicated that it will likely approve Epidiolex. Although the recommended use for this particular product is very limited, doctors may prescribe it at their discretion.
“Both by Lennox-Gastaut syndrome and Dravet syndrome are rare, severe, refractory epilepsy syndromes with onset in early childhood,” the FDA stated.
“The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome (LGS and DS),” the FDA said in briefing documents given to the advisory committee ahead of Thursday’s meeting.
“In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders.”
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