For the first time, the US Food and Drug Administration has approved a drug made from cannabis. Epidiolex treats severe forms of childhood epilepsy — but the Drug Enforcement Administration will need to reclassify this form of cannabis before the drug can be put on the market.
For almost half a century, the DEA has classified cannabis as a Schedule I drug, along with heroin and LSD. (For context, cocaine and meth are Schedule II drugs.) Schedule I drugs are considered to have “no currently accepted medical use and a high potential for abuse. “ As a result, it is extremely difficult for scientists to research the substance and pharmaceutical companies aren’t allowed to use it.
But now the FDA has approved Epidiolex as a medical drug. Epidiolex contains cannabidiol, or CBD — a chemical that comes from the cannabis plant but does not have psychoactive effects — and is administered as an oil. According to DEA spokesperson Melvin Patterson, the administration had been considering reclassifying CBD and “the FDA’s findings on something like Epidiolex will weigh heavily on the decision-making process. Still, there’s no update on whether the approval will change the timeline of the proposed reclassification. The DEA could also reclassify CBD, but leave cannabis itself at Schedule I.
Epidiolex treats two forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, which rarely respond to treatment. It is manufactured by GW Pharmaceuticals and clinical trials have shown that kids taking Epidiolex had nearly 40 percent fewer seizures per month.
The scope of the drug is limited, and the approval is for “a single compound that comes from the plant and is approved for two very specific forms of epilepsy,” said Daniel Friedman, an associate professor of neurology at NYU Langone’s Comprehensive Epilepsy Center who co-authored a study investigating Epidiolex to treat Dravet syndrome. But doctors could prescribe it off-label for other forms of epilepsy, and FDA approval could be the domino effect that leads to DEA reclassification and a renaissance of cannabis research.
We have reached out to GW Pharmaceuticals for comment and will update the post if the company responds.