Article by Laurie McGinley, Washington Post
Food and Drug Administration advisers on Thursday unanimously supported the first-ever government approval of a medication made from cannabis, paving the way for agency clearance by the end of June.
The drug, Epidiolex, would be administered in a syrup form and is made from a purified ingredient in cannabis called cannabidiol, or CBD. It is intended to treat severe seizures in children caused by rare forms of epilepsy called Lennox-Gastaut and Dravet syndromes.
Most patients with those diseases have uncontrolled daily seizures despite treatment, putting them at high risk for developmental disabilities, serious injury and premature death, the FDA staff said in background materials released this week.
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 drug does not contain THC, the psychoactive component in cannabis. The FDA staff said the drug “has a negligible abuse potential.”