Cannibidiol Rescheduling Clears Way for Distribution of FDA-Approved Cannabis-Derived Treatment for Dravet and Lennox-Gastaut Syndromes
The FDA-approved formulation of cannabidiol (CBD)(Epidiolex; GW Pharma, Carlsbad, CA) has been rescheduled by the Drug Enforcement Agency (DEA), clearing the way for marketing and distribution of the drug. The FDA approved CBD is for the treatment of seizures in patients, age 2 years and up, who have Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS).
Most importantly, this historic milestone will make CBD of reliable and verified dosing and quality available for patients who until now have had limited or no treatments. In clinical trials, the FDA-approved CBD significantly reduced the frequency of drop seizures for patients with LGS by as much as 41.9% compared to a 17.2% decrease seen with placebo. For patients with DS, this is the first efficacious drug approved drug. In studies, patients with DS treated with the FDA-approved CBD experienced decreases in seizure frequency of 39% compared to a 13% decrease seen with placebo.
As noted by Justin Gover, GW Pharma’s Chief Executive Officer when CBD was approved, this is “the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”
The DEA’s decision moves the FDA-approved formulation of CBD (ie, CBD containing no more than 0.1% delta-tetrohydrocannibinol [THC]) to the least restrictive category from the most restrictive category of controlled substances. This formulation of CBD is now a Schedule 5 substance, defined as medically useful with lowest potential for abuse among controlled drugs. Previously, all forms of CBD as derivatives of the cannabis plant (marijuana) were designated Schedule 1, defined as having no medical benefit with highest potential for abuse. Schedule 1-designated substances are illegal to possess or distribute under federal law. Although state laws vary considerably and over 30 states have legalized marijuana use for medicinal purposes, marijuana and all derivatives of it except the FDA-approved CBD remain illegal at the federal level as Schedule 1 substances.
This landmark decision also paves the way for more research on the medicinal uses of cannabis-derived substances as noted by Acting DEA administrator Uttam Dhillon, who said, “(the) DEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective.” This echoes the statement of FDA Commissioner Scott Gottlieb, MD who said, “The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high quality products,” when CBD was approved in June 2018.