US Food and Drug Administration — FDA News Release — June 25, 2018

The Food and Drug Administration (FDA) on June 25, 2018 approved a new drug, a derivative from marijuana, to treat patients with two forms of epilepsy. GW Pharmaceuticals developed Epidiolex, made from cannabidiol or CBD, a marijuana component that does not cause “highs.” The drug was shown to decrease by 40 percent the number of seizures in patients with Dravet and Lennox-Gastaut syndromes.

"The FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. 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. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality 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. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases."

Source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm

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