Back in late 2018, the FDA granted Breakthrough Therapy status to the ongoing work from COMPASS Pathways investigating psilocybin, the key psychoactive compound in magic mushrooms, as a therapy for treatment-resistant depression. A large, multi-center Phase 2 trial spanning the US, UK and Europe is currently underway testing a variety of dosing strategies.
This new FDA Breakthrough Therapy approval focuses on a seven-site, Phase 2 trial currently underway in the United States. Coordinated by a non-profit research organization called the Usona Institute, the trial is exploring the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder.
Last year's Breakthrough Therapy designation was targeted at the drug's efficacy for treatment-resistant depression (TRD).