Federal advisers voted Thursday to recommend approval of the first cannabidiol medicine — to treat rare and severe forms of epilepsy.
The advisory committee to the Food and Drug Administration unanimously voted to recommend approval of the drug, known as Epidiolex.
Cannabidiol — CBD for short — is a cannabis derivative and the approval would be limited to treating seizures caused by Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients aged 2 and older.
“Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death,” said Philip Gattone, president and CEO of the Epilepsy Foundation.
The internet is awash in CBD products. It’s being sold as a sleep aid and cancer cure, pain medicine and anxiety reliever. Most of the claims are unsubstantiated by careful medical studies and have become so blatant that the FDA has issued warnings to companies that make them.
This product is different.
A British company, GW Pharmaceuticals, has gone through the testing necessary to be considered for FDA approval.
Its carefully formulated product will have to be made under guidelines, called good manufacturing practices, so that buyers can count on getting what is supposed to be in the bottle.
A bottle of Epidiolex, a CBD drug made from marijuana, but without THC. Kathy Young / AP File
The FDA has indicated that it would approve the drug. Although doctors may prescribe any FDA approved product as they see fit, the recommended use for this particular product is very limited.
“Both by Lennox-Gastaut syndrome and Dravet syndrome are rare, severe, refractory epilepsy syndromes with onset in early childhood,” the FDA said.
It’s not clear how or why CBD works, but studies show it does, the FDA said.