The Food and Drug Administration (FDA) has given the green light to a marijuana-derived prescription medication that could be used to treat rare forms of epilepsy. An FDA panel recommended Epidiolex for approval in April and this is the first drug derived from the cannabis plant to win federal approval.
“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,” said FDA Commissioner Scott Gotlieb in the announcement. “This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition.”
Epidiolex is an oral medication derived from cannabidiol, also called CBD, which is one of more than 100 chemical compounds found in the cannabis plant. CBD does not contain tetrahydrocannabinol, or THC, the chemical component that causes that notorious marijuana high.
The drug was developed for severe, early-onset epilepsy syndromes such as Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex and infantile spasms — all of which are conditions that primarily affect children and are marked by frequent and severe seizures. Roughly 1 million patients live with uncontrollable seizures because there are no available medications or treatments that can be used to manage their symptoms, according to the Scientific American.
During the public hearing to review Epidiolex, 16-year-old Sam Vogelstein of Berkeley, California, told the panel, “I had seizures for 10 years … there were times I had seizures 100 times a day.” But Vogelstein noted that since he began taking Epidiolex, he has been seizure-free for more than two years. “It changed my life,” he said.
More than two dozen states currently allow the use of marijuana for the treatment of various conditions, but the FDA has never approved it for medical use.
The FDA’s approval limits the use of the Epidiolex to epilepsy patients, but health care providers would be able to prescribe it for other uses, potentially opening up new avenues of research and interest in marijuana-based medications.