FDA Approves Cannabis-Based Drug For First Time Despite Active Ingredient Being Schedule I Substance
The U.S. Food and Drug Administration (FDA) approved a drug derived from marijuana for the first time on Monday, despite the active ingredient still being a Schedule I controlled substance.
The drug, Epidiolex, treats seizures in two epilepsy conditions, Lennox-Gastaut syndrome and Dravet syndrome, according to an FDA press release on Monday. Epidiolex is approved for patients 2 years and older.
The active ingredient in the drug is cannabidiol, or CBD, rather than tetrahydrocannabinol, or THC. THC is the compound in marijuana that produces a high by changing how the brain communicates with the body, according to the National Institute on Drug Abuse’s website. Therefore, Epidiolex cannot get someone high.
CBD is technically a Schedule I controlled substance under the Controlled Substances Act, meaning that it is considered a drug “with no currently accepted medical use and a high potential for abuse,” according to the Drug Enforcement Administration’s (DEA) website. Epidiolex was able to be approved by the FDA despite this because “the company conducted nonclinical and clinical studies to assess the abuse potential of CBD,” according to the press release.
“Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients,” FDA Commissioner Scott Gottlieb said in the press release. (RELATED: New York Approves Medical Marijuana For Pain Patients To Deal With ‘Unprecedented’ Opioid Crisis)
Marijuana’s potential for treating medical conditions and their side effects is increasingly being recognized. Patients can currently obtain medical marijuana in 29 states and in Washington, D.C.