FDA Approves Medical Mushrooms Trial

By David Jenison on August 31, 2018

The federal government already recognizes medical cocaine, and it finally gave medical cannabis a partial nod this past summer, but the next shoe to drop may well be medical mushrooms. In yet another step toward this eventuality, the Food and Drug Administration (FDA) approved a clinical trial that will test the efficacy of psilocybin-based medicine in reducing treatment-resistant depression. 

Psilocybin is the naturally occurring psychedelic compound in shrooms, and Neuropharmacology published studies in 2017 and 2018, among other studies and research, that reaffirmed its potential for treating depression. 

COMPASS Pathways, who received the FDA approval for the trial, already received regulatory approvals from the Netherlands, Canada, and the U.K. for the study. The British life sciences company launched in 2016 with the intent to develop psilocybin-based therapies for treatment-resistant depression. The phase IIb trial will include 216 patients treated with a combination of psilocybin and psychological support in at least a dozen research sites across Europe and North America. A successful trial should lead to phase III studies. 

To think, the FDA argued against rescheduling cannabis and affirming its medical benefits just two years ago. Since then, the same FDA gave MDMA special status as a "breakthrough therapy" for post-traumatic stress disorder (PTSD), and now it's approved a study on the medical value of mushrooms. The FDA also approved the first cannabis-derived medicine (Epidiolex) in June, and the scheduling of the drug next month might include changes to the status of cannabis and/or specific cannabinoids (e.g., cannabidiol).  

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