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The first FDA-approved cannabis-derived drug is available for prescription in the US

a bottle of GW Pharmaceuticals’ Epidiolex
AP Photo/Kathy Young
The drug is the first cannabinoid product approved by US regulators.
  • Jenni Avins
By Jenni Avins

senior lifestyle correspondent

Published This article is more than 2 years old.

As of today (Nov.1), US doctors in all 50 states can legally prescribe an FDA-approved drug that contains compounds found in cannabis.

Epidiolex, a fruit-flavored liquid marketed to treat two forms of severe childhood epilepsy from the British company GW Pharmaceuticals, became the first cannabis-derived drug to be approved by the FDA in June of this year. The decision pointed to the many inconsistencies between US agencies where cannabis is concerned. Although according the US Drug Enforcement Agency (DEA), marijuana is still a schedule I substance—meaning that it has no medical use and high potential for abuse—Epidiolex was classified as a low-restriction schedule V substance in September.

Epidiolex contains cannabidiol—the chemical compound also known as CBD—which is increasingly popular for its reported abilities to deliver relief from maladies such as anxiety, joint pain, insomnia, and nausea. And while Epidiolex is approved specifically for treating two potentially fatal forms of severe childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, there’s a good chance it will be prescribed for “off-label” use. This practice of doctors prescribing drugs to treat conditions outside of the ones it is approved for is legal and common, according to the US Department of Health and Human Services.

“The off-label use of CBD and Epidiolex will be a fascinating subject to look at over the coming years,” Orrin Devinsky, the director of the Comprehensive Epilepsy Center at NYU Langone Health and the lead investigator of two clinical trials of Epidiolex, told CNN.

“Many, many patients would like to have access to it who don’t fit the criteria, and I believe many doctors will try to prescribe it, as will I for some people who I think have tried many, many medications and for whom it might be beneficial.”

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