FDA committee supports first CBD epilepsy drug
A U.S. Food and Drug Administration (FDA) advisory committee on Thursday unanimously supported approval of the first-ever epilepsy drug derived from cannabis for prescription use in the United States.
The FDA will vote in June whether to approve the drug, Epidiolex, which would be administered in a syrup form and taken orally. The drug is made from a plant-based, purified ingredient in cannabis known as CBD, and is intended to treat severe forms of epilepsy, according to Greenwich Biosciences, the UK-based pharmaceutical company that would market the drug.
Most patients who would take the drug would have uncontrolled daily seizures despite treatment, putting them at high risk for developmental disabilities, serious injury, and premature death, according to the FDA.
CBD is one of more than 80 active cannabinoid chemicals, yet unlike tetrahydrocannabinol (THC), it does not produce a high.
The unanimous support of the 13-member FDA advisory committee seemed assured after agency staff members gave the drug a positive review, saying clinical trials showed it was effective at reducing seizures, and side effects, including possible liver complications, could be managed. The precise mechanism by which CBD reduces seizures isn't known, the FDA said.
The FDA isn't required to follow the recommendation of its advisory committees, though historically it does. An FDA approval would be targeted to specific epilepsy patients, but once approved the drug could be prescribed for other uses.
Market analysts say approval could pave the way for other cannabis-based drugs. Though CBD is known in the integrative medicine field, the drug may offer additional opportunity for integrative healthcare practices.