(Rachel Feltman/ Popular Science) —The U.S. Food and Drug Administration (FDA) has given the hallucinogenic compound psilocybin, known for giving “magic mushrooms” their mind-altering powers, a “Breakthrough Therapy” designation for the second time in just over a year.
This designation, which is designed to expedite the development and review of drugs—given out only for therapies that have shown strong preliminary evidence in treating serious medical conditions—puts new pharmaceuticals on a fast track for approval and offers “intensive guidance” from the FDA.
In October 2018 the FDA granted a Breakthrough Therapy designation to COMPASS Pathways for its use of psilocybin in addressing treatment-resistant depression (TRD).
As the name suggests, this condition is defined by depressive symptoms that don’t improve with the use of two or more standard therapies. Also, in March 2019, the FDA approved a TRD nasal spray (designed to mimic the positive effects of the hallucinogenic ketamine) as the first new antidepressant in decades. (…)