FDA Approves First Cannabis-Derived Drug For Medical Use

FDA approves first ever drug derived from marijuana | TheHill

First marijuana-derived drug approved, will target severe epilepsy

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. It's not yet clear why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.

The Drug Enforcement Administration (DEA) classifies marijuana or cannabis as a Schedule 1 substance - which means there is "no now accepted medical use and a high potential for abuse".

"This is an important medical advance", Gottlieb said.

"The FDA prepares and transmits... a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the [Controlled Substances Act]", the FDA stated, indicating that it will recommend that CBD be rescheduled but the act of shifting the substance's legality is ultimately in the DEA's hands.

Ohio's medical marijuana program was expected to be operational in early September but now has no definite start date, and none of the approved cultivation centers has begun growing the plant.

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With Epidiolex meeting FDA standards, the drug will "finally be made available to the thousands that may benefit from it", he said. Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness.

There are side effects, the most common being sleepiness, Gover said.

Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer "drop" seizures - in which her entire body goes limp and collapses.

He added: "We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant".

Why? Because their product and company status will no longer exist in the legal gray area, and hopefully the mass confusion over which CBD products are legal and which are not will come to an end.

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Epidiolex, manufactured by GW Pharmaceuticals in the United Kingdom, is made from cannabidiol, the non-psychoactive part of the cannabis plant.

FDA's Gottlieb warned about the use of CBD products with "unproven medical claims". "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery". "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

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.

Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use.

Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA. Experts expect to see an uptick in cannabidiol-related products out of Canada, particularly with this week's nationwide legalization of marijuana. Others said they are anxious to try an FDA-approved product.

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