FDA Grants 'Breakthrough Status' to Another Psilocybin Drug for Depression

This is the second drug using the magic mushroom compound to be fast-tracked by the FDA.
Fabienne Lang

When you think of magic mushrooms your mind most likely jumps to images of brightly colored hallucinations. That's certainly one way some might experience the fungus, but there's another, more useful, usage. 

Psilocybin, the hallucinogenic compound found in 'magic' mushrooms, has medical uses too. It helps to treat major depressive disorder (MDD), or what we simply call depression. 

The Food and Drug Administration (FDA) has given psilocybin a 'Breakthrough Therapy' designation, meaning its development and review will be fast-tracked. 


This is not the first time psilocybin is fast-tracked by the FDA

This is not the first time the FDA fast-tracks hard drugs to help treat depression.

In October 2018, the FDA gave the Breakthrough Therapy designation to COMPASS Pathways, which used psilocybin for assisting treatment-resistant depression (TRD). This is a type of depression that doesn't improve, even after two or more standard therapies have been tried.

Then, in March 2019 it approved a TRD nasal spray that mimics the effects of ketamine — another hallucinogenic drug. 

Now, the FDA is enabling another psilocybin trial. 

Given that TRD is said to affect approximately 5 million U.S. citizens, and MDD affects around 17 million in the nation, the FDA's approval is welcome. Moreover, hundreds of millions of people around the world are affected by depression. 

Who received the Breakthrough Therapy designation?

This latest FDA designation goes to the Usona Institute, a nonprofit medical research institute focusing solely on finding ways to treat depression. 

Researchers at the Institute hope to find ways of "understanding the therapeutic effects of psilocybin and other consciousness-expanding medicines."

Currently, the Institute launched their second phase of the clinical trial, and are looking for 80 participants to take part in their study. The aim of their trial is to determine the efficacy of treating depressed patients with one single oral dose of psilocybin. 

The positive effects of psilocybin in lowering the symptoms of depression have already been proven from past research. The key takeaway from this research is that a combination of taking these drugs and undergoing specialized talk therapy simultaneously is chief in providing lasting relief from mental illness. 

The reason psilocybin is being trialed to treat depression is that when ingested, it targets and decreases activity in the amygdala part of the brain. This section of the brain regulates fear and anxiety, and when psilocybin is taken it regulates the amygdala. 

Side effects of the drug are still numerous and high, hence the importance of taking it in very specific and controlled situations is paramount. 

It's currently illegal to cultivate or possess psilocybin-inducing fungi in the U.S., so don't try this at home just yet. 

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