The first FDA-approved drug derived from marijuana was announced Monday by the federal agency.
Epidiolex, a cannabidiol oral solution, was approved by the U.S. Food & Drug Administration. It will treat seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome. It is for patients ages 2 and up.
CBD is one of 80 active chemicals in marijuana, and it is not the intoxicating substance in pot. THC, not CBD, is the primary psychoactive component of marijuana, according to the FDA.
“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,” said FDA Commissioner Scott Gottlieb, M.D. “And, the FDA is committed to this kind of careful scientific research and drug development.”
Gottlieb added, “This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use.”
The FDA granted approval of Epidiolex to GW Research Ltd.