By Rich Haridy, New Atlas
November 24, 2019
The US Food and Drug Administration (FDA) has granted psilocybin therapy a Breakthrough Therapy designation for the second time in a year, this time with a view on accelerating trials testing its efficacy treating major depressive disorder (MDD).
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). That particular clinical classification categorizes patients suffering from MDD who have not responded effectively to at least two different pharmacological antidepressant treatments during a current depressive episode. It is estimated between 10 and 30 percent of MDD patients fall into the category of TRD.
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