The Food and Drug Adminstration’s approval of Epidiolex, a medication derived from cannabis, could be life-changing for Americans suffering from certain types of epilepsy. It may also have far-reaching implications for U.S. marijuana policy.
Epidiolex, made by GW Pharmaceuticals, is the first medication derived from the cannabis plant ever approved by the FDA. It has in the past approved synthetic formulations of tetrahydrocannabinol (THC), the active ingredient in marijuana. The FDA’s decision directly contradicts the decision by the Drug Enforcement Administration to keep the newly approved compound, cannabidiol, under the umbrella of marijuana as a Schedule I substance, since by definition drugs in that class have no medicinal benefit.
An external FDA advisory panel recognized as much when it stated in April that cannabidiol would need to be rescheduled before legal sales of Epidiolex could begin. More importantly, a DEA representative recently affirmed that outlook, telling Leafly reporter Ben Adlin that if Epidiolex is approved, the DEA will “absolutely” reschedule CBD.
Rescheduling cannabidiol means the DEA would remove this substance from its list of Schedule I prohibited substances, which includes drugs like heroin, LSD, and ecstasy. The administration would then presumably reclassify cannabidiol in a less restrictive schedule (the DEA has five drug schedules, with Schedule I being the most restrictive and Schedule V being the least restrictive). Cannabidiol would still be considered a controlled substance, but it would be permitted for legal medical use under certain circumstances.
A science-based therapy
If the DEA reschedules cannabidiol, that would be the beginning of cannabis-derived compounds being recognized by top federal agencies as a legitimate medicine. Rescheduling cannabidiol paves the way for other advanced cannabinoid formulations, like the ones currently being researched and developed by scientists on staff at my Colorado-based cannabinoid science business, ebbu. We’ve known for years that cannabidiol is a powerful cannabinoid with legitimate and proven medical properties.
Evidence for the ability of cannabidiol to ease treatment-resistant epilepsy syndromes is strong. Last year, researchers funded by GW Pharmaceuticals published in the New England Journal of Medicine findings of a double-blind, placebo-controlled trial of cannabidiol in 120 children and young adults suffering from a severe form of childhood epilepsy called Dravet syndrome. Those taking Epidiolex experienced dramatic reductions in the frequency of seizures. Similar results were reported in a Phase 3 placebo-controlled trial among 171 patients with Lennox-Gastaut syndrome published this year in the Lancet.
Not long after the NEJM report, GW Pharmaceuticals, which operates in the U.S. as Greenwich Biosciences, applied for FDA approval of Epidiolex.
Beyond epilepsy
FDA approval of Epidiolex could open the door to cannabis-based treatments for a number of other conditions.
Scientists at the University of Washington published a compelling report last fall in the Proceedings of the National Academy of Sciences demonstrating the effectiveness of cannabidiol in a mouse model of epilepsy and autism.
Scientists have been investigating cannabinoids for the treatment of skin conditions such as pruritus, inflammatory skin disease, and skin cancer. This spring, researchers from the University of Naples Federico II and Consiglio Nazionale delle Ricerche published the first conclusive evidence supporting the anti-inflammatory properties of cannabidiol in experimental allergic contact dermatitis.
The FDA’s first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way. High-quality research that taps into the wide-ranging potential therapeutic applications for cannabidiol is vital for the future of its legitimate use in medicine.
Jon Cooper is the CEO of ebbu, a multiplatform cannabinoid technology company.
