Just months after we dedicated a week to the magnificent mushroom, the FDA has approved psilocybin, the hallucinogenic compound of magic mushrooms, as a Breakthrough Therapy for the second time this year.
This designation means research can be fast-tracked into psilocybin’s application for treating the major depressive disorder (MDD).
The drug was initially approved as a Breakthrough Therapy due to work by COMPASS Pathways. The new designation focuses on work by Usona, a non-profit research group specifically looking into treatment resistant depression (TRD). The group is in phase two of an experiment working with 80 human patients, which should be completed by 2021.
The Breakthrough Therapy designation was first created by the FDA in 2012 for therapies intended for accelerated approval of drugs that display treatment advantages over current options for serious or life-threatening conditions.
Approving psilocybin in this category is a significant step for the FDA, which previously denounced the drug for recreational and medical purposes. But thanks to an increase in recent research surrounding the therapeutic properties of psilocybin, government institutions are becoming more open to its beneficial properties.