FDA Approves First Cannabis-Derived Drug For Medical Use

FDA Approves First Cannabis-Derived Drug For Medical Use

FDA Approves First Cannabis-Derived Drug For Medical Use

The drug, Epidiolex, is made up of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.

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.

The FDA is approving this new drug, despite it still being considered a Schedule 1 drug by the Drug Enforcement Agency. The decision caps decades of work by the company to gain approval in the USA for a medicine derived from the cannabis plant. 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. Many individuals report experiencing relief from epilepsy symptoms after smoking a high CBD strain of cannabis or consuming CBD pills, which exclusively or primarily contain cannabidiol. Epidiolex had previously received Fast Track Designation and Orphan Drug Status from the FDA.

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". Despite the medication's approval, cannabis remains a Schedule I substance, which, according to the federal government, means it has "no accepted medical uses".

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The DEA did not immediately respond to Ars' request for comment.

A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall.

GW Pharmaceuticals Plc's epilepsy treatment on Monday secured an approval from the U.S. Food and Drug Administration, becoming the first cannabis-based drug to be approved in the country. Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness.

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Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. Almost 70 percent of those products had different amounts of CBD than were specified on the product label, with many testing positive for the psychotropic THC even though the products are legally not supposed to have any THC.

Many families have moved to states where marijuana is legal medically or recreationally so they could treat their children with CBD on their own.

"We'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products", Gottlieb said. "There's no time line or clock that starts ticking on us".

"Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", he said.

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"This is an important medical advance", said US Food and Drug Administration Commissioner Scott Gottlieb. FDA officials said the drug reduced seizures when combined with older epilepsy drugs.

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