On June 25, 2018, the Food and Drug Administration (FDA) approved the first drug comprised of an active ingredient derived from marijuana: Epidiolex. Designed to treat seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, Epidiolex is a purified (> 98% oil-based) cannabidiol (CBD) extract from the cannabis plant administered via an oral spray.
According to FDA Commissioner Scott Gottlieb:
“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.”
Prior to receiving FDA approval, Epidiolex underwent a number of clinical trials, demonstrating the efficacy of cannabis in treating epilepsy. For instance, in a randomized double-blind, placebo-controlled trial performed at 30 clinic centers, researchers found that the addition of CBD to traditional seizure medication significantly decreased the rate of drop (or atonic) seizures.