The FDA has granted Breakthrough Therapy designation to psilocybin for the treatment of major depressive disorder.
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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 trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.