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.
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