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Regulatory Focus™ > News Articles > 6 > FDA Approves First Marijuana-Derived Drug

FDA Approves First Marijuana-Derived Drug

Posted 25 June 2018 | By Michael Mezher 

FDA Approves First Marijuana-Derived Drug

The US Food and Drug Administration (FDA) on Monday approved the first-ever marijuana derived drug—GW Pharmaceuticals' Epidiolex (cannabidiol)—to treat seizures that present with two rare forms of epilepsy.

Specifically, the drug contains a purified form of cannabidiol, or CBD, and is indicated to treat patients two years and older with Lennox-Gastaut syndrome and Dravet syndrome. FDA also emphasized that CBD does not cause the high associated with tetrahydrocannabinol (THC).

The approval comes after FDA's Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted in favor of approving the drug in April.

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies," said FDA Commissioner Scott Gottlieb, noting that the approval only applies to one CBD-based medication and does not apply to marijuana or other compounds found in marijuana.

Gottlieb stressed that the clinical studies and research conducted as part of the drug development process for Epidiolex will ensure that patients receive a product with "uniform strength and consistent delivery," as opposed to other CBD-containing products that have not undergone rigorous study or FDA review.

Gottlieb also said the agency will continue its enforcement efforts against illegally marketed CBD-containing products but noted that it will prioritize those efforts against companies marketing unapproved products based on the seriousness of their claims.

While marijuana remains a Schedule I drug and is illegal under federal law, some 30 states and the District of Columbia, Guam and Puerto Rico have legalized the medical use of marijuana, and nine of those states and the District of Columbia have approved recreational marijuana use.

According to Douglas Throckmorton, deputy director of regulatory programs at the Center for Drug Evaluation and Research, said that the Drug Enforcement Agency (DEA) "will need to make a different scheduling decision for CBD because it now has an accepted medical use."

Throckmorton added that FDA is currently working with DEA on that scheduling decision but said he could not comment on what Schedule CBD would be placed into.

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