Thu. Dec 1st, 2022
A close-up of a hand holding a small marijuana leaf in front of a blurred background
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Marijuana now has an accepted medical use.

The U.S. Food and Drug Administration announced today, Monday, June 25, approval of the country’s first marijuana-based prescription medication. The drug is called Epidiolex and is a plant-derived oral solution of cannabidiol (CBD) – a chemical component of marijuana that does not cause intoxication or a euphoric “high”. The FDA approved it for use in patients two years of age and older who suffer from rare and severe forms of epilepsy known as Lennox-Gastaut syndrome and Dravet syndrome, which can develop early in childhood. The approval of Epidiolex also marks the first time the FDA has approved a drug to treat Dravet syndrome.

With the landmark approval, the London-based company behind the drug, GW Pharmaceuticals plc, expects another consistent decision in the coming weeks: to get the US Drug Enforcement Administration to reclassify CBD. The move could open the doors to other marijuana-derived drugs and ease heavy restrictions on marijuana-related research.

Currently, CBD – like other marijuana components – is classified as a Schedule I drug by the DEA. Schedule I drugs include heroin and LSD, as well as marijuana. They are defined as substances with a high abuse potential and “no current accepted medical use”. As such, Schedule I drugs are strictly regulated and their use, including medical use, violates federal law. GW will not be able to market Epidiolex until the DEA reclassifies CBD.

But the agency is expected to do just that. The FDA noted in its announcement today that it is informing and advising the DEA on scheduled substances. In April, an FDA expert advisory panel voted unanimously to recommend the approval of Epidiolex, finding that “CBD has negligible abuse potential.”

The DEA did not immediately respond to Ars’s request for comment. But GW said it expects the DEA to reschedule CBD in 90 days.

In a statement, GW CEO Justin Gover said:

Today’s approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD drug for the treatment of two severe childhood-onset epilepsy… These patients deserve and will soon have access to a cannabinoid drug that has been thoroughly studied in clinical trials, manufactured to ensure quality and consistency, and available by prescription under the care of a physician.

Patients, parents of children with severe epilepsy, and some researchers have long suspected CBD’s potential to treat the devastating epileptic conditions. In some cases, patients have moved to states that have legalized medical marijuana to access the drug. But CBD products available in stores may have unreliable concentrations or poor quality controls. A survey late last year found that nearly 70 percent of CBD products sold online were mislabeled.

“Controlled clinical trials testing a drug’s safety and efficacy, along with careful review by the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients,” FDA Commissioner Scott Gottlieb said today in a statement.

He continued:

We continue to support rigorous scientific research into the potential medical uses of marijuana-derived products and partner with product developers interested in bringing high-quality, safe and effective products to patients. But at the same time, we are ready to take action if we see CBD-containing products being illegally marketed with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations, can prevent patients from accessing appropriate, recognized therapies for the treatment of serious and even fatal diseases.

Today’s approval “reminds us that advancing development programs that properly evaluate the active ingredients in marijuana could lead to important medical therapies. And the FDA is committed to this kind of careful scientific research and drug development,” Gottlieb concluded.

In deciding to approve Epidiolex, the FDA reviewed data from three high-quality clinical trials that showed CBD reduced seizure frequency relative to placebo in more than 500 patients with one of two intractable and debilitating forms of epilepsy.

The FDA noted that the most common side effects of Epidiolex were drowsiness, sedation and lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise and weakness, insomnia, sleep disturbance and poor quality sleep, and infections.

By akfire1

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