According to a press release sent out this morning, the U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) for the treatment of seizures associated with two forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.
This marks the first time the FDA has ever approved a drug that contains a substance that was directly derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies”, says FDA Commissioner Scott Gottlieb, M.D. And, the FDA is committed to this kind of careful scientific research and drug development”.
Gottlieb continues; “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,