Psilocybin FDA Approved

FDA Lists Psilocybin as “Breakthrough Therapy” for Depression Second Year in a Row

For the second year in a row, the US Food and Drug Administration (FDA) has designated psilocybin, the psychedelic compound found in many of the most popular hallucinogenic mushrooms, as a “breakthrough therapy,” for the treatment of major depressive disorder (MDD).

Treatments that are classified as breakthrough therapies are fast-tracked through the development and review process, which is often an extremely slow process filled with mountains of paperwork. This classification is not taken lightly, and is only granted in cases where a large body of evidence shows that that the new therapy is a significant improvement to its alternatives. Typically, drug companies apply for this designation, which is either approved or denied by the FDA. Last year, the first breakthrough therapy designation for psilocybin was granted to the company Compass Pathways.

Compass Pathways launched in the UK in 2016 thanks to funding from PayPal founder Peter Thiel. This year, the designation was granted to the US-based nonprofit Usona Institute, which is conducting clinical trials for treating depression with psilocybin.