A Historic Decision by the DEA
On September 27, 2018, the US Drug Enforcement Agency (DEA) announced it was placing the childhood epilepsy drug, Epidiolex, on schedule V of the Controlled Substances Act (CSA). Epidiolex was recently approved by the US Food and Drug Administration (FDA). What is interesting and important about this move by the DEA is that Epidiolex contains a marijuana (cannabis) extract called cannabidiol or CBD. CBD does not produce a ‘high’ — a different extract called tetrahydrocannabinol (THC) is responsible for that effect. Cannabis has been categorized as a schedule I drug (with “no accepted medical use”) since the CSA was passed by the US Congress in 1970.
Cannabis Has a “Currently Accepted Medical Use”
This approval of a CDB drug by the FDA demonstrates that cannabis has a therapeutic capability. The action by the DEA of placing a CBD drug on schedule V further validates the benefits of cannabis. This is because schedule V drugs must have “currently accepted medical use” according to the CSA.
This is a historic moment in the evolution of understanding naturally-occurring substances classified as illegal drugs. It marks the first time since marijuana was outlawed in 1970 that the federal government has acknowledged the therapeutic benefits of one of the 113 cannabinoids it contains. FDA Commissioner Scott Gottlieb says:
“Adequate and well-controlled clinical studies supported Epidiolex approval, so prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.”
What Does This Mean for Psilocybin and Psilocin?
Dr. Gottlieb makes a critical point about current efforts to use psilocybin/psilocin as therapeutic drugs. Only recently have studies been designed and conducted using measured amounts of psilocybin and psilocin to find therapeutic doses to treat specific conditions. In previous studies, volunteers were often given measured amounts of psilocybin mushrooms. We know from laboratory studies that Psilocybe species vary widely in the type and amount of hallucinogenic chemicals they contain. Therefore, using mushrooms makes it impossible to standardize accurate doses that are delivered precisely every time.
This landmark scheduling decision of CDB by the DEA reveals that government regulators are open to the results of logical, controlled, data-driven studies using known quantities of chemicals—even if it involves an extract of a schedule I drug. The studies currently underway using psilocybin and psilocin are major steps in the right direction. Also, the recent recommendation from the Johns Hopkins School of Medicine to move psilocybin to schedule IV adds enormous strength and credibility to the cause.
However, all the physiologically active chemicals in “magic mushrooms” must be identified and their effects and interactions understood. This includes the currently identified chemicals baeocystin, norbaeocystin, and aeruginascin. This will give a clear “big picture” of their nature and open the door to understanding all their therapeutic possibilities.
**What do you think about the DEA scheduling of this CBD drug? How does it impact the future of psilocybin/psilocin therapies? Please let us know your thoughts in the comments section below.