FDA Grants “Breakthrough Therapy” Status for Magic Mushrooms to Treat Depression

In a move that will likely come as a surprise to many, the Food and Drug Administration (FDA) has granted Breakthrough Therapy status to psilocybin, which is the psychedelic ingredient found in magic mushrooms.

The Breakthrough Therapy status was granted for the use of psilocybin to treat depression. The move comes after research commissioned by the government found that the substance shows great promise in the treatment of depression.

The designation of Breakthrough Therapy allows the FDA to expedite research and review of treatments containing psilocybin (or psilocybin itself). Currently a Phase IIb trial is underway attempting to determine the optimal dose range for psilocybin to treat severe treatment-resistant depression.

The FDA’s Breakthrough Therapy designation was created in 2012, and was designed to give certain substances a faster pathway to approval.

1 comment

  1. Psilocybin research has been going on for many, many years at Harvard McClean hospital, John-Hopkins with M.A.P.S. and others. This may be very beneficial to people with depression & end of life anxiety issues and especially helpful to people that suffer from CLUSTER HEADACHES. (See “Clusterbusters.org” – A non-profit organization with real data and real results from decades of research on real patients using real & natural ingredients).
    Psilocybin IS MEDICINE and is non-addictive ! I’ve NEVER heard of anyone taking a fatal overdose of psilocybin.

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