The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).
It is THC (and not CBD) that is the primary psychoactive component of marijuana.
“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. And, 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
To date, cannabis and all cannabinoids are Schedule 1 controlled substances. But since the FDA approval for a medicinal use of cannabis/CBD, this could lead to a rescheduling of cannabis under the Controlled Substances Act.
GW Pharmaceuticals’, Justin Gover, stated that the FDA approval is “a recognition that the plant is a rich source of compounds which have potential therapeutic activity.”
If rescheduling does in fact proceed, it could open the floodgates for more scientific testing and opportunities in the cannabis industry.
