After evaluating the abuse potential of medical psilocybin based on the 8 factors of the US Controlled Substance Act (CSA), researchers from Johns Hopkins University School of Medicine suggest that the active ingredient in “magic mushrooms” should be rescheduled from a Schedule I to a Schedule IV agent, once the drug clears Phase 3 clinical trials.
Currently, psilocybin, a serotonin receptor agonist, is classified as a Schedule I drug as it has not been approved by the Food and Drug Administration (FDA) for any therapeutic use. Based on their recently published review, the researchers believe that compared to typical drugs of abuse, the potential harms associated with psilocybin seem low and are manageable when administered according to a medical model that addresses these concerns.
“We want to initiate the conversation now as to how to classify psilocybin to facilitate its path to the clinic and minimize logistical hurdles in the future,” said Matthew W. Johnson, PhD, associate professor of psychiatry and behavioral sciences at Johns Hopkins. “We expect these final clearance trials to take place in the next 5 years or so.”
Psilocybin is currently being investigated by COMPASS Pathways in a Phase 2b trial for treatment-resistant depression. The trial includes 216 patients and was approved by the FDA last month; if successful, the Company intends to start Phase 3 trials.
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