The U.S. Food and Drug Administration approved the drug Epidiolex back in June, but GW Pharmaceuticals, the maker of Epidiolex, needed to wait until the Drug Enforcement Administration recategorized its compounds from their listing as Schedule 1 drugs before the company could begin selling it. That recategorization has now happened, and the drug is now available for sale in all 50 states.
Epidiolex uses a marijuana derivative that is helpful in treating a rare form of epilepsy called Lennox-Gastaut Syndrome (LGS) and a genetic brain dysfunction called Dravet syndrome. Both syndromes can cause seizures. But Epidiolex, with its marijuana derivative, has been found to reduce a certain type of those seizures by as much as 25% to 28%, reports CNN.
Announcing the commercial availability of the drug, FDA Commissioner Scott Gottlieb said: “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. 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.”