FDA Grants Psilocybin A Breakthrough Therapy For Depression

Psilocybin is the psychoactive compound in magic mushrooms. It’s like what THC is to weed; it is the substance that is going to allow you to trip. The US Food and Drug Administration (FDA) has granted psilocybin a Breakthrough Therapy for treating Major Depressive Disorder (MDD), also known as clinical depression. This marks the second year in a row the FDA has recognized the benefits of the shrooms’ chemical.

Currently, a large Phase 2 trial is underway in US, UK, and Europe. They are testing a variety of dosing strategies looking to find the ideal amount that will calm the brains of subjects. The trials have been coordinated by a non-profit research organization called the Usona Institute. They hope to discover the antidepressant properties of a single dose of psilocybin.

The Breakthrough Therapy designation will look to target subjects who suffer from treatment-resistant depression (TRD). This type of depression is for patients who have not responded effectively to at least two different pharmacological antidepressant treatments. It is common in between 10% and 30% of MDD patients. Usona’s director had this to say about the experiments:

“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials.”

It seems so often recently that we are hearing of the benefits of drugs previously looked down upon. MDMA has also had some major breakthroughs lately leading the way for other “recreational” drugs. Microdosing psychedelics, like mushrooms and LSD, have also shown to have remarkable effects on users.

Usona estimates the current Phase 2 trial should be completed by early 2021. If it continues to get positive remarks from the FDA an even larger Phase 3 trial will be in order.