The U.S. Food and Drug Administration on Monday approved the first cannabis-derived drug for sale, which has shown to control seizures in children with life-threatening forms of epilepsy.
Epidiolex, manufactured by GW Pharmaceuticals in the UK, is made from cannabidiol, the non-psychoactive part of the cannabis plant. It was made for children 2 and older who are diagnosed with Dravet syndrome and Lennox-Gastaut syndrome, two serious forms of epilepsy that cause life-long developmental delays.
It’s not clear how quickly the drug will be available for prescription.
The goal is have it available in pharmacies by the end of the year, said Orrin Devinsky, a pediatric neurologist and director of the New York University-Langone and Saint Barnabas Comprehensive Epilepsy Center in Livingston, who co-authored the research.
First, the FDA must confer with the Drug Enforcement Administration to decide when to “reschedule” cannabidiol, better known as CBD, Devinsky said.
Cannabis, including CBD, is a “schedule 1” drug, meaning it has no medicinal value and poses a high risk for abuse. This status has stifled rigorous research, because the federal government will not pay for it.