U.S. approves Epidiolex, first marijuana-derived drug


But it's not quite medical marijuana.

The Food and Drug Administration approved the first cannabis-derived drug on Wednesday.

In fact, this was the third clinical trial to show that Epidiolex is useful in treating two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, Devinsky said. Once the FDA approves the drug, expected by the end of June, doctors will be able to prescribe it legally.

With the historic approval, the London-based company behind the drug, GW Pharmaceuticals plc, is expecting another consequential decision in the coming weeks: getting the US Drug Enforcement Administration to reclassify 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.

CBD has medicinal effects, but it does not cause the mind-altering high that comes from THC, the primary psychoactive component of marijuana. Schedule I drugs include heroin and LSD as well as marijuana.

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FDA officials noted the significance, signaling a new approach to looking at a plant still defined in federal law as having "no now accepted medical use".

For medical marijuana advocates, it's a clear vindication of a fundamental premise of a decadeslong movement: that cannabis can have legitimate medical applications and it isn't the bogeyman that the federal government has long made it out to be.

But the agency is expected to do just that.

Ironically, an advisory panel for the FDA unanimously approved the recommendation for Epidiolex one day before 4/20.

The DEA did not immediately respond to Ars' request for comment. GW Pharma says about 6,000 to 10,000 have Dravet Syndrome. Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness.

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According to Dr. Angel Hernandez, of the Helen DeVos Children's Hospital in Grand Rapids, Mich., these results prove that pharmaceutical-grade CBD helps suppress seizures and "increases our options to treat many of these patients with very, very difficult-to-control epilepsies".

Another 20 states allow medical marijuana, but the USA government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD. CBD oil and infused products have popped up on health food and grocery store shelves. A study at the end of previous year found that almost 70 percent of CBD products sold online were mislabeled.

Despite today's approval, the FDA acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is "prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims".

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said.

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

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