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Epidiolex

In Historic Move, FDA Advisory Committee Recommends Approval of World’s First Phytocannabinoid-Based Drug, Epidiolex

An FDA advisory panel unanimously voted to recommend approval of Epidiolex. Epidiolex is CBD-based pharmaceutical intended for the treatment of epilepsy, and the first cannabinoid-based drug to be considered for approval by the FDA, according to The New York Times. The FDA is expected to complete its review process by June 27th.

Approval of Epidiolex means that researchers will now be able to advance research into CBD’s effects on epilepsy and other conditions.

A thirteen-member FDA panel—the Peripheral and Central Nervous System Drugs Advisory Committee—met on April 19th to consider the evidence for the safety and efficacy of what they termed, “Cannabidiol Oral Solution” (CBD-OS). Their recommendation will now be passed along to the FDA.

The committee unanimously agreed that Epidiolex is, indeed, safe and efficacious in treating seizures in patients two years of age and older suffering from Lennox-Gastaut syndrome and Dravet syndrome. They are considered some of the most severe forms of epilepsy.

If approved, the drug is expected to be covered under the DEA’s controlled substances list as a Schedule IV drug. Schedule IV drugs include prescription-only sleep and pain medications.

Cannabis researchers are applauding the move.

“This is a very good development, and it basically underscores that there are medicinal properties to some of the cannabinoids,” Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California San Diego told The New York Times.

However, Daniel Friedman, an associate professor of neurology at NYU Langone’s Comprehensive Epilepsy Center and co-author of a study investigating Epidiolex to treat Dravet syndrome, points out that Epidiolex is “a single compound that comes from the plant and is approved for two very specific forms of epilepsy.”  

"It's incredibly important as a physician prescribing to patients that we know what we're giving them and we know we give them one month will be the same that we give them three or six months later," said Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center. "It's very important to highlight that the drug used in this study, cannabidiol, was derived from cannabis plants, and purified to 99 percent purity.”

Dr.Devinsky added, "This is not something you can get from a dispensary today in the United States. It's not something that you can get by smoking marijuana. It is a very specific pharmaceutical grade product derived from marijuana, but quite different than what is available anywhere else right now in the United States."

Although it’s not fully understood how CBD works, studies show that it does, the FDA said. And, although the recommended use for Epidiolex is limited to seizure reduction—“Both by Lennox-Gastaut syndrome and Dravet syndrome are rare, severe, refractory epilepsy syndromes with onset in early childhood,” the FDA said—doctors may prescribe any FDA approved product as they see fit.

“The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome (LGS and DS),” the FDA claims. “In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders.”

The likely approval of Epidiolex is expected to spur more drug developers to look into CBD’s medicinal benefits.

According to NBC News, the Centers for Disease Control and Prevention reported Thursday that epilepsy diagnoses are becoming more common in the U.S. Three million adults reportedly suffer from epilepsy. This is up from 2.3 million in 2010.

It’s important to point out that, although cannabis-based medicine is prohibited on a federal level, epilepsy and LGS patients in a majority of U.S. states already have legal access to CBD as a result of state medical marijuana programs.

The FDA briefing document which was supplied to the committee can be found here.