The U.S. Food and Drug Administration (FDA) approved a cannabis-based epilepsy medication today. The medicine, Epidiolex, is the first drug derived directly from cannabis approved by the regulatory agency.
The FDA has previously approved medications with synthetic versions of cannabinoids such as THC. But Epidiolex is the first drug containing a botanical extract from cannabis plants to receive approval.
Epidiolex is a flavored oral solution with cannabidiol (CBD) that reduces seizures in children with epilepsy. The medicine, which is not psychoactive, also contains less than 0.1 percent THC. Drug manufacturer GW Pharmaceuticals produces Epidiolex at its facilities in the U.K. After researchers found the drug effective in clinical trials, the company filed for FDA approval last year.
The FDA is currently considering approving the drug to treat Lennox-Gastaut (LGS) and Dravet syndromes, two severe forms of epilepsy. Earlier this year, an FDA advisory panel unanimously recommended approval for Epidiolex. The panel decided that the benefits of Epidiolex outweighed the risks for children two-years-old and up with LGS and Dravet Syndrome.
In an announcement of the approval, FDA Commissioner Scott Gottlieb, M.D. said that the agency is also willing to consider other medical marijuana treatments that complete the regulatory process.
“This approval serves