FDA and DEA approve CBD-based epilepsy medication10.03.18
Late last month, the U.S. Drug Enforcement Administration (DEA) issued a final order placing FDA-approved drugs that contain cannabidiol (CBD) derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V of the Controlled Substances Act of 1970 (CSA).
Schedule V of the CSA includes drugs such as Robitussin and Lyrica. That's a big step because previously the DEA had provided guidance that CBD would be considered as included in the parts of the cannabis plant that fall within the CSA definition of marijuana, a Schedule I drug. Schedule I is reserved for abuse-prone products that “have no currently accepted medical use,” and includes drugs such as Fentanyl and heroin, as well as all other marijuana products.
The DEA’s order was issued as a result of a recommendation by the Food and Drug Administration (FDA), and was based on the FDA’s own approval over the summer of GW Pharmaceuticals PLC’s (NASDAQ:GWPH) Epidiolex product (whose main active ingredient is CBD) for treatment of two types of epilepsy.
Like the DEA’s order, the FDA’s clearance was seemingly a reversal from the agency previous crackdowns on the unapproved marketing of CBD, which is often promoted by supplement companies as a pain-relief aid.
In the wake of the FDA and DEA’s approval, GW Pharmaceuticals issued a press release stating that it anticipates making Epidiolex available within six weeks from September 27, 2018. As Epidiolex is currently the only FDA-approved CBD product on the market, it will be interesting to gauge the amount of time it takes other drug manufacturers to follow suit in creating their own CBD-based products.