A pharmaceutical derived from cannabis currently up for approval by the U.S. Food and Drug Administration earned an endorsement in a clinical trial published in The New England Journal of Medicine today, May 17. The drug, made with cannabidiol (CBD), was at the center of a bill recently passed by the Colorado General Assembly to ensure its distribution in Colorado — contingent on FDA approval — despite its illegal status with the federal government.
Epidiolex, a cannabis-derived CBD drug made by a subsidiary of GW Pharmaceuticals, was given to 149 patients enrolled in the study suffering from Lennox-Gastaut syndrome, a severe form of epilepsy, while 76 patients were given placebos. Funded by GW Pharma and conducted by the New York University Langone School of Medicine, the study found the CBD medication “resulted in greater reductions in the frequency of drop seizures” than placebos.
“This new study adds rigorous evidence of cannabidiol’s effectiveness in reducing seizure burden in a severe form of epilepsy and, importantly, is the first study of its kind to offer more information on proper dosing,” the study’s co-author, Orrin Devinsky, said in a statement. “These are real medications with real side effects.”
A little over 32 percent of participants receiving 10-milligram doses of Epidiolex on top of their conventional anti-epileptic regimen experienced at least a 36.4 percent drop in seizures, while just under 42 percent of those receiving 20 milligrams saw a 38.4 percent reduction or greater. However, those taking the medication faced risks of higher aminotransferase concentrations in the liver, known for increasing inflammation and damaging the liver.
Epidiolex is expected to receive FDA approval within the next month, but the agency’s blessing of a plant-derived cannabis medicine doesn’t supersede the plant’s Schedule I status with the federal government. In order to allow Colorado physicians and pharmacists to legally prescribe and dispense the drug, the state legislature approved a bill in April that gives Epidiolex a pass over federal law similar to Marinol, a pharmaceutical that uses synthetic THC.
The bill was sent to Governor John Hickenlooper on May 1 and is still awaiting his signature.