The Department of Justice and the U.S. Drug Enforcement Administration (DEA) have cleared the use of the medicine Epidiolex by placing it in schedule V of the Controlled Substances Act (CSA).
Schedule V is the least restrictive classification of the CSA, meaning that the agent is considered to have low potential for abuse as it contains a low amount of a narcotic compound, in this case the cannabis plant-derived compound cannabidiol (CBD).
“[The] DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,” Uttam Dhillon, acting administrator of the DEA, said in a press release. “DEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective.”
Epidiolex is a purified form of CBD, the most abundant non-psychoactive cannabinoid compound in the cannabis plant. CBD can mimic natural compounds that act on brain receptors, which when faulty can cause seizures.
Results from two Phase 3 clinical trials (NCT02091375 and NCT02224703) including 189 Dravet patients revealed that treatment with Epidiolex could reduce convulsive seizures by 38-44% and all seizures by 39-51%.
The treatment has also been shown to improve overall health and clinical status in roughly 80% of patients at six months and one year of treatment.
“Adequate and well-controlled clinical studies supported Epidiolex’s approval, so 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,”said FDA Commissioner Scott Gottlieb, MD.
“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,” he added.
Epidiolex is the first therapeutic agent containing a purified extract from the cannabis plant to be approved by the FDA. It is also currently under review by the European Medicines Agency, with a final decision being expected in the first quarter of 2019.