CBD epilepsy treatment wins unanimous approval from FDA
CBD epilepsy treatment wins unanimous approval from FDA advisers
A CBD treatment for epilepsy is closer to becoming the first cannabis medicine approved for the U.S. market.
A panel of government health advisers gave a unanimous recommendation Thursday to the U.S. Food and Drug Administration to approve Epidiolex, a CBD medicine for rare epilepsy conditions that don’t respond to other drugs.
British drugmaker GW Pharmaceuticals is seeking FDA approval to sell the drug in the United States.
“We owe it to these patients and families to identify new treatments,” said Dr. Orrin Devinsky, a neurologist who specializes in epilepsy at New York University.
The panel voted 13-0 to suggest FDA approval after hearing presentations on the drug’s effectiveness and safety.
On Tuesday, the FDA had posted its own review of Epidolex, saying that “data in the application appears to support approval” for the new drug.
The FDA’s physicians said the drug has a low potential for abuse, and that it doesn’t produce euphoric effects seen from THC.
The advisory panel’s recommendation doesn’t bind the agency to approving Epidiolex, but its recommendations carry serious weight.
The FDA has said it will issue a decision by late June.
A representative from GW Pharmaceuticals declined to say whether the CBD in Epidiolex comes from hemp or marijuana, simply describing the source as a “proprietary strain of the cannabis plant.”
He also declined to say where the plants are being grown.
When asked, the FDA said cannabis likely would be rescheduled in the Controlled Substances Act if Epidiolex is approved, though the final decision would be made by the U.S. Drug Enforcement Administration and the FDA’s parent agency, the U.S. Department of Health and Human Services.
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