Psilocybin Gets Breakthrough Therapy Designation for Treatment-Resistant Depression

Psilocybin, the active ingredient in "magic mushrooms", has been granted Breakthrough Therapy designation by the FDA for treatment-resistant depression.

Psilocybin, the active ingredient in “magic mushrooms”, has been granted Breakthrough Therapy designation by the Food and Drug Administration (FDA) for treatment-resistant depression

The designation was granted to COMPASS Pathways, a life sciences company investigating psilocybin in a Phase 2b trial involving 216 patients at multiple sites across Europe and North America. “The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible,” said George Goldsmith, Executive Chairman of COMPASS Pathways. 

Discussing the outcomes of a proof-of-concept study conducted at Imperial College of London, Dr Robin Carhart-Harris, Head of the Psychedelic Research Group said, “In our 2015 study, we provided psilocybin to 19 patients in a clinical setting, coupled with psychological support, and found promising signals of efficacy and safety as treatment for treatment-resistant depression. The Breakthrough Therapy designation is a strong endorsement for the potential of psilocybin therapy.”

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Currently, psilocybin, a serotonin receptor agonist, is classified as a Schedule I drug in the US as it has not been approved by the FDA for any therapeutic use. According to a recent study published in the journal Neuropharmacology, the potential harms associated with psilocybin seem low and manageable when administered in a medically supervised setting. Based on their findings, the study authors went on to suggest that the drug should be rescheduled to a Schedule IV agent once it clears Phase 3 trials.

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This article originally appeared on MPR