Cannabis Medicine To Treat Epilepsy Officially Approved By FDA

FDA approves first ever drug derived from marijuana | TheHill

The drug, GW Pharmaceuticals' Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high.

Lennox-Gastaut syndrome also causes seizures, usually starting in children aged 3 to 5. Epidiolex's approval also marks the first time the FDA has approved a drug to treat Dravet syndrome.

The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant. The move could open the doors to other marijuana-derived medications as well as ease heavy restrictions on marijuana-related research. But federal regulations classify CBD as a Schedule 1 drug, similar to heroin and cocaine, because it is a chemical component of the cannabis plant.

"For a maligned substance like cannabis, I think the vindication tour will ultimately be years long", said Ricardo Baca, a former marijuana editor at the Denver Post, and the founder of Grasslands, a cannabis PR agency.

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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". Epidiolex had previously received Fast Track Designation and Orphan Drug Status from the FDA. The administration would then presumably reclassify cannabidiol in a less restrictive schedule (the DEA has five drug schedules, with Schedule I being the most restrictive and Schedule V being the least restrictive).

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

Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision.

Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.

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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. It is indeed a pressing issue for the CBD industry, as there is a large variation in the quality and efficacy of CBD products in the marketplace.

"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said. FDA chief Scott Gottlieb said his agency had supported research on cannabis-derived products "for many years". 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.

"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. "And, the FDA is committed to this kind of careful scientific research and drug development".

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