COMPASS Pathways announced that the Food and Drug Administration (FDA) has granted approval for a clinical trial with psilocybin therapy for treatment-resistant depression.
The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America. It is set to start in the United Kingdom later this month and sites in other countries will join the trial as additional regulatory approvals are received. If the Phase 2b trial is successful, the Company plans to conduct Phase 3 studies to compare the optimal dose with placebo or standard of care.
Psilocybin therapy consists of a dose of the psychoactive agent psilocybin, a serotonin receptor agonist, with psychological support; psilocbyin is the active ingredient found in “magic mushrooms”. Previous research, including a study published in The Lancet Psychiatry, suggests that this combination provides immediate and sustained reductions in depression and other conditions. Psilocybin has also been investigated in the treatment of anxiety and depression in distressed cancer patients and as a possible smoking cessation therapy.
For more information visit CompassPathways.com.