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IPFS News Link • Drugs and Medications

Psilocybin for major depression granted Breakthrough Therapy by FDA

• https://newatlas.com by Rich Haridy

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). 


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