July 16, 2018

FDA Green Lights Marijuana-Based Pharmaceutical Drug

26 June 2018, 05:58 | Silvia Roy

United States regulators on Monday approved the first marijuana-derived drug ever to hit the U.S. market, Epidiolex, which will be used to treat 2 rare and severe forms of childhood epilepsy.

Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals.

Epidiolex contains CBD, which does not produce the "high" associated with marijuana.

The federal thumbs-up comes on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring.

On a call with reporters on Monday, FDA Commissioner Scott Gottlieb, M.D., cautioned that Epidiolex's green light is not an approval for marijuana but an approval for "one specific CBD medication for a specific use" based on well-controlled clinical trials.

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".

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An advisory panel to the FDA recommended in April that the drug be approved. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD. It's in phase 3 testing for a potential approval in the U.S. The company is also working on cannabinoid programs against glioblastoma, schizophrenia and more.

Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome.

But before the medicine can hit the market in those areas, the Drug Enforcement Administration must reclassify marijuana, now a Schedule I drug, along with heroin and Ecstasy, that is described as a substance with "no now accepted medical use and a high potential for abuse". The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents.

That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts.

The study also showed that Epidiolex is a safe treatment, with only seven patients dropping out of the trial due to side effects - six from the 20-mg group and one from the 10-mg group.

It's not clear how quickly the drug will be available for prescription.

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Patients are concerned that changes to state laws to allow for the first cannabis-derived medication in pharmacies could limit their access to cannabis medicine at dispensaries.

Epidiolex won't require a special certification to prescribe, Patel said, and it's likely physicians will prescribe it for off-label uses.

At time of publication, GW Pharma shares had receded to trade down 1.7 percent on the day - a potential case of "buying the rumor, selling the news" considering GW's pre-approval run.

The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year.

The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption.

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