The FDA is helping to speed up the process of researching and approving psilocybin, a hallucinogenic substance in magic mushrooms, to treat major depressive disorder (MDD).
For the second time in a year, the U.S. Food and Drug Administration (FDA) has designated psilocybin therapy currently being tested in clinical trials as “breakthrough therapy,” an action that is meant to accelerate the typically sluggish process of drug development and review. It is typically requested by a drug company and granted only when preliminary evidence suggests the drug may be an enormous improvement over already available therapy, according to the FDA.
Last year, the FDA granted “breakthrough therapy” status to psilocybin therapy in the still-ongoing clinical trials run by the company Compass Pathways, which are looking into psilocybin’s potential to treat severe treatment-resistant depression, or depression in patients who have not improved after undergoing two different antidepressant treatments, according to New Atlas.
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