In a previous post, we discussed GW Pharmaceuticals, the leading developer of cannabis-based pharmaceuticals. 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 announcement is important for several reasons.
First, although the FDA has previously approved drugs using synthetic THC as the active ingredient (Marinol, Sydros, and Cesamet), Epidiolex is the first approval for a purified drug substance derived from marijuana plants.
Second, this is the first approval for cannabidiol (CBD), which is not psychoactive, unlike tetrahydrocannabinol, (THC), which is.
Third, and perhaps most importantly, the approval of Epidiolex could present the Drug Enforcement Administration (DEA) with an opportunity to review the status of cannabinoids under the Controlled Substances Act (CSA). Currently, CBD from marijuana is a Schedule I substance because it is a chemical component of the marijuana plant. In support of the Epidiolex new drug application, GW Pharmaceuticals conducted clinical and nonclinical trials assessing the abuse potential of CBD, a critical factor in determining appropriate scheduling under the CSA. This means that DEA will likely now consider the appropriate CSA scheduling of Epidiolex in light of these data. It is too early to tell whether DEA will reschedule Epidiolex, but DEA has previously approved Schedule II and Schedule III status for THC-containing products Marinol, Sydros, and Cesamet.
Finally, 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 should 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.