The FDA has approved Epidiolex (cannabidiol [CBD]) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients age 2 and older. Epidiolex is the first FDA-approved drug that contains a derivative of marijuana. It also is the first drug approved by the FDA for the treatment of Dravet syndrome.
The approval was based on three randomized, double-blind, placebo-controlled clinical trials that included 516 patients with Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex taken with other epilepsy medications reduced the frequency of seizures, compared with placebo. The most common side effects included lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, sleep disorder, and infection.
“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,” said FDA Commissioner Scott Gottlieb, MD. “We will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products…. 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.”
Scott Gottlieb, MD
CBD, a component of Cannabis sativa, does not cause intoxication or euphoria, unlike tetrahydrocannabinol (THC), the plant’s primary psychoactive component. CBD currently is a Schedule I substance because it is a chemical component of the cannabis plant. The Drug Enforcement Administration (DEA) is expected reschedule CBD within 90 days.
Epidiolex will be marketed in the US by Carlsbad, California-based Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals, which is headquartered in London. Access to Epidiolex is expected to be similar to that for other branded antiepileptic drugs, and the treatment is expected to be available by Fall 2018, the company said.
