An FDA expert panel unanimously recommended the approval of Epidiolex.
Photo: AP Images

This year, the Food and Drug Administration is joining stoners the world over in celebrating 4/20.

Just kidding. But on Thursday, an expert panel did unanimously recommend that the agency approve a new drug made from cannabis to treat two severe and rare forms of epilepsy. If approved, the drug, called Epidiolex and made by GW Pharmaceuticals, would be the country’s first medication derived from pot.

Advertisement

The 13-0 vote from the advisory panel is not compulsory, but it paves the way for the drug’s approval. A decision is expected this summer. In a briefing document on the drug compiled by FDA officials for the panel, agency officials wrote that the drug resulted in “clinically meaningful” and “statistically significant” reductions in seizures during clinical trials.

Epidiolex, which comes in the form of a syrup-like oral medication, contains cannabidiol, or CBD, a component of cannabis that does not result in a high. CBD oil has long been used for its suspected ability to calm seizures, and groups like the American Epilepsy Society have promoted its use. It’s generally seen as a low-risk ingredient, and with medical weed legal in 29 states, its now hawked as an unsubstantiated cure-all for everything from sleepless nights to cancer. In places like California where weed is legal, things like beverages containing CBD are readily available at the corner market.

But data suggests CBD really might be effective for treating seizures. Epidiolex’s drug aims to treat Lennox-Gastaut and Dravet syndromes, two severe epilepsy disorders that typically emerge in young children. Both disorders have a high mortality rate, and Dravet syndrome patients often die before age 10.

Advertisement

GW Pharmaceuticals conducted three randomized, double-blind, placebo-controlled trials with the drug. Studies showed that taking CBD reduced seizures in Lennox-Gastaut and Dravet syndrome patients by more than 40 percent. The drug did not work for all patients, and the drug did cause side effects of sleepiness and gastrointestinal issues for some people. The FDA also noted in its briefing that there is the possibility of drug-induced liver injury, though noted that it is too early to tell whether chronic liver injury could occur. Such concerns, though, could be mitigated with careful monitoring.

“In general,” the agency wrote, “the risks associated with cannabidiol appeared to be acceptable.”

The FDA has previously approved synthetic medications that resemble or mimic THC, the component of cannabis that makes people high, to treat nausea from chemotherapy, among other conditions.

Advertisement

Though attitudes toward pot are certainly shifting, the Drug Enforcement Administration continues to classify cannabis as a Schedule I drug, a classification that indicates it has no proven medical value and a high risk of abuse. If the drug is approved, the DEA will have to reschedule cannabidiol.