The first-ever FDA-approved drug that contains cannabidiol (CBD), one of the chemicals present in marijuana, won’t face the kind of restrictions that marijuana and other cannabis-oriented products do.
The DEA (Drug Enforcement Agency) has determined that Epidiolex, which the FDA approved in June for treatment of seizures associated with two types of epilepsy, is a Schedule V drug. This means it has a low potential for abuse. In contrast, marijuana is listed as a Schedule I drug, meaning it has a high potential for abuse as well as no currently accepted medical purpose.
Epidiolex does not contain THC, the compound in cannabis that can give users a high. It is important to note that the FDA didn’t reschedule CBD itself as a Schedule V drug, but rather FDA-approved drugs containing the compound. CBD by itself is still considered a Schedule I drug.
GW Pharmaceuticals, Epidiolex’s developer, said it expects its product to be available in six weeks. And it isn’t cheap: Epidiolex has a price tag of $32,500 per year.
Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.