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How Will FDA Treat Drug Derived from Cannabis?

Epidiolex, a drug derived from cannabis, is up for approval by the FDA. What will the agency determine?

FDA staffers have reviewed data for an epilepsy drug derived from cannabis. They have written that the application is well done and that the balance of risks and benefits looks good.

Drug Derived from Cannabis for Intractable Childhood Epilepsy:

The cannabidiol compound is called EPIDIOLEX. The company submitted data to the FDA for the treatment of two rare types of hard-to-treat epilepsy in children, Dravet syndrome and Lenox-Gastaut syndrome. Some of these youngsters have not responded to other epilepsy medications.

The medicine does not contain tetrahydrocannabinol, the compound responsible for marijuana’s psychedelic effects. Consequently, there is no risk that children taking this pharmaceutical drug derived from cannabis would get high. There is, however, a potential risk of liver injury. The medication does not seem to be effective for all cases, and some youngsters found that it upset their stomachs or made them sleepy.

How Will the Agency Decide?

FDA approval is not guaranteed, but the advisory panel met today, April 19, 2018.  These outside advisors unanimously recommended that the agency approve Epidiolex.  At this point, the final determination is now up to the FDA. If the drug gets the green light, it will be the first FDA-approved medicine to be made from marijuana plants.

Pharmaceutical vs Plant Product:

It seems quite possible that the FDA will approve Epidiolex, given recommendations from the staff and the advisory committee. If so, this drug derived from cannabis will be treated in every respect as a pharmaceutical. The British manufacturer, GW Pharmaceuticals, will be able to sell this prescription product throughout the country, not just in states where medical marijuana is legal.

Some parents of children with these intractable epilepsy conditions have moved their families to states where they can legally obtain marijuana or CBD oil. They report success in certain cases using these natural products. But doses can be difficult to control because of the natural variability of plant products. As a result, doctors will probably be more comfortable prescribing Epidiolex for children with these rare conditions.

Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center, told NBC News:

“It’s incredibly important as a physician prescribing to patients that we know what we’re giving them and we know [what] we give them one month will be the same that we give them three or six months later…It’s very important to highlight that the drug used in this study, cannabidiol, was derived from cannabis plants and purified to 99 percent purity. This is not something you can get from a dispensary today in the United States.”

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies..
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