FDA approves Epidiolex (purified CBD), the first FDA-approved prescription medication derived directly from the cannabis plant
On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex—an oral cannabidiol (CBD) solution for rare childhood epilepsy syndromes—forcing the DEA to reschedule a plant-derived cannabinoid for the first time.
On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved Epidiolex, a purified, plant-derived cannabidiol (CBD) oral solution for the treatment of seizures associated with two rare and severe forms of childhood-onset epilepsy: Lennox-Gastaut syndrome and Dravet syndrome in patients aged two years and older.
Why Epidiolex was a scientific and legal breakthrough
While the FDA had previously approved synthetic THC medications made in a laboratory—such as dronabinol (Marinol, approved in 1985) and nabilone (Cesamet)—Epidiolex was the first FDA-approved prescription drug extracted directly from the cannabis plant, backed by three randomized, double-blind, placebo-controlled clinical trials involving 516 patients.
- Forcing the first DEA scheduling shift: Because a drug approved by the FDA cannot legally remain in Schedule I (“no currently accepted medical use”), the DEA placed Epidiolex in Schedule V—the least restrictive schedule of the Controlled Substances Act—in September 2018.
- Full descheduling in 2020: Following the passage of the December 2018 Farm Bill, the DEA removed Epidiolex from the Controlled Substances Act schedules altogether in April 2020, meaning prescriptions no longer required DEA controlled-substance tracking.
Originally reported by U.S. Food and Drug Administration (FDA)
Sources (2)
- U.S. Food and Drug Administration, FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy (June 25, 2018). https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms
- Drug Enforcement Administration, Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Cannabidiol in Schedule V, 83 Fed. Reg. 48950 (September 28, 2018; descheduled entirely in April 2020 following the 2018 Farm Bill).
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