FDA Approves First Drug Derived From Marijuana Plant

FDA Approves First Drug Derived From Marijuana Plant

FDA Approves First Drug Derived From Marijuana Plant

The Food and Drug Administration on Monday approved the country's first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.

A new drug derived from marijuana just became the first of its kind to get the green light from the United States government.

For those who have long argued that cannabis offers medical benefits, an FDA approval represents a milestone, "a recognition that the plant is a rich source of compounds which have potential therapeutic activity", Justin Gover, chief executive of GW Pharmaceuticals, the London-based company that developed the drug, said in an interview last week.

The federal thumbs-up comes on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring.

The approval could spur more research into marijuana products, though marijuana itself remains illegal.

"This is an important medical advance", FDA Commissioner Dr. Scott Gottlieb said in a statement Monday.

Epidiolex, made by the British company GW Pharmaceuticals, is now marketed to treat two forms of severe childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

Parents treated their children's seizures with CBD oil years before the FDA backed any drug. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade 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. She has not used Epidiolex in her own clinical practice and was not involved in the development of the drug but said she's not sure it will live up to "all of the hype" that has surrounded it. This is called off-label use and is a common practice with many medications.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV.

"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said.

"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.

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", said the FDA.

The FDA is not required to follow the advisory panel's advice but usually does. "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".

Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

Across the board, the drug was shown to be effective in cutting the frequency of seizures. That decision is expected within 90 days. European approval is expected in early 2019.

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