The FDA has just approved a new drug for epilepsy, and that drug is cannabis-derived. In a first, Epidiolex, was approved for the relief of certain types of epilepsy. Today, the FDA announced the approval of GW Pharmaceutical’s drug Epidiolex (cannabidiol), an oral solution for treatment of seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients two years of age and older.
This news has broken the mold on FDA approval of cannabis medication. The cannabidiol in this medication is naturally derived from cannabis plants instead of being synthetically produced. It is also the first approval for cannabidiol as a medicine. The approval has also opened the door to re-scheduling of cannabidiol from a Schedule II substance, a status it maintains simply for being a product of the cannabis plant.
the FDA confirmed that while it continues to support the development of medical marijuana therapies, it does so only under the existing drug approval process. According to FDA Commissioner Scott Gottlieb, M.D.:
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high-quality products.”
CBD producers please note that FDA Commissioner Gottlieb makes clear that this does not mean that CBD is now legal:
“But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
Regardless of how Epidiolex is eventually scheduled, it’s now approved, and GW Pharmaceuticals’ aggressive research and development program has pushed the cause of medical marijuana one large step forward.
This is a huge step forward for the cannabis industry as some of the enormous potential of the cannabis plant is now becoming understood. It is news to most people that CBD helps with the treatment of epilepsy, unless you happen to work with medical cannabis. If you do, you have known about this for some time.