The U.S. Food and Drug Administration approved June 25, 2018 a prescription drug made from marijuana for the first time. The drug, known as Epidiolex, is approved to treat seizures in two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.
Epidiolex is made from cannabidiol, or CBD, which is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. CBD does not cause intoxication or euphoria that comes with the use of tetrahydrocannabinol (THC) which is the main psychoactive ingredient of marijuana.
Under the federal Controlled Substances Act, marijuana (including CBD) currently is classified as a Schedule I drug. The CSA categorizes drugs into five categories depending on the drug’s acceptable medical use and the drug’s abuse or dependency potential. Schedule I drugs are defined as drugs with no currently accepted medical use and a high potential for abuse. Schedule I drugs are considered the most dangerous and include marijuana, heroin, LSD and Ecstasy, among others.
Before sales of Epidiolex commence, the Drug Enforcement Administration must formally reclassify CBD into a different category so that it may be used for medical purposes. That decision is expected within 90 days.
It is possible that the FDA’s approval of this drug could be a first step toward the eventual reclassification of marijuana. In 2016, the DEA denied petitions to reschedule marijuana from a Schedule I drug to a Schedule II drug, because the research did not yet support a reclassification. At that time, the DEA stated that the current medical and scientific evidence demonstrated that marijuana has no currently accepted medical use in treatment in the United States. (Click here for our blog post on that decision). However, the DEA also stated that it supported legitimate medical and scientific research concerning the use of marijuana and that if the scientific understanding about marijuana changed, the DEA’s decision also could change.