BreakThrough Psilocybin Therapy Announced by the FDA

Have you heard this incredible news from the Federal Drug Administration (FDA)? Since 2018, the FDA has been assisting in the development and approval of psilocybin, a hallucinogenic chemical found in magic mushrooms, as a treatment for major depressive disorder (MDD). The US Food and Drug Administration has certified psilocybin treatment, which is now being studied in clinical studies, as “breakthrough therapy” for the second time in 2019. Breakthrough treatment is a strategy for speeding up the generally slow process of medication research and approval. According to the FDA, it is normally requested by a drug firm and approved only when preliminary data shows the treatment may be a significant improvement over currently available therapy.

Now, COMPASS Pathways has reported that their FDA-designated breakthrough medicine has shown promising outcomes in the treatment of treatment-resistant depression. In the next year, we may hear even more about the use of psilocybin in the treatment of depression. In this guide, we’ll explain what the FDA has announced for psilocybin therapy for depression.

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Customer Note: In the United States, the cultivation of magic mushroom spores and consumption or psychedelic use of grown fruit bodies is currently illegal on a federal level. All of our Mushroom Spore Syringes for sale by Shaman Mushroom Spores are for the purpose of mycology research and microscopy study only.


Psilocybin Therapy Announced by the FDA Twice in 2019

The US Food and Drug Administration (FDA) designated psilocybin therapy as a Breakthrough Therapy twice in 2019, the second time to expedite research examining its efficacy in the treatment of serious depression.

The FDA granted Breakthrough Therapy classification to COMPASS Pathways’ ongoing research into psilocybin, the major hallucinogenic ingredient in magic mushrooms, as a treatment for treatment-resistant depression in late 2018. A broad, multi-center Phase 2 trial that spans the United States, the United Kingdom, and Europe is still underway, evaluating various dosage regimens.

This recent FDA Breakthrough Therapy approval is for a seven-site Phase 2 experiment that is now taking place in the United States. The experiment, which is being coordinated by the Usona Institute, is looking at the antidepressant qualities of a single psilocybin dosage in the treatment of individuals with severe depressive disorder.

The drug’s effectiveness for treatment-resistant depression was the focus of the Breakthrough Therapy designation in 2018. (TRD). Patients with MDD who have not reacted adequately to at least two separate pharmacological antidepressant therapies during a current depressive episode fall into this clinical category. TRD affects between 10% and 30% of MDD patients, according to estimates.

The current FDA approval focuses on Usona’s study into MDD, which is defined as periods of severe depression lasting more than two weeks. Every year, hundreds of millions of individuals throughout the world suffer from acute major depressive episodes.

It’s been several years since the breakthrough therapy designation was given, so what has happened with these clinical trials? Before we dive into it, it helps to understand exactly what breakthrough therapy actually is.


Understanding What Breakthrough Therapy Is

Before we get into how psilocybin spores and fruit bodies can be used to treat depression, it helps to understand the legal roadblocks in place that have kept psilocybin study in a box. Psilocybin, sometimes known as “magic mushrooms,” is a hallucinogenic substance generated naturally by psilocybin mushrooms. It is classed as a Schedule I restricted drug in the United States, meaning it has “no established medicinal use and a significant potential for abuse.” The Controlled Substances Act of 1970 made the substance illegal. Oregon voters approved Ballot Measure 109 in November 2020, making it the first state to decriminalize psilocybin and legalize it for medicinal use. Despite state legislation, the use, sale, and possession of psilocybin in the United States are unlawful under federal law.

Psilocybin mushroom spores can be used to significantly improve lives on a medical level, which makes this illegal designation really unfortunate. Luckily, the FDA has been assigning breakthrough therapy status to a few different research institutes– which means the study of psychedelic mushroom spores could be used for medical purposes.

According to the FDA, Breakthrough Therapy designation is a procedure that expedites the development and approval of pharmaceuticals that are intended to treat a severe ailment and early clinical evidence suggests that the treatment may show significant improvement over existing therapy on clinically relevant endpoints.

The size of the therapeutic impact, which might include the duration of the effect, and the relevance of the observed clinical result are both factors that must be considered when determining whether the improvement above available treatments is significant. In general, preliminary clinical data should demonstrate a demonstrable benefit over currently available treatment.

A clinically meaningful endpoint, for the purposes of Breakthrough Therapy designation, is one that evaluates an effect on irreversible morbidity or mortality (IMM) or symptoms that signify major disease consequences. Findings that imply an influence on IMM or major symptoms are also considered clinically meaningful endpoints.


The FDA’s Efforts to Facilitate the Study of Psilocybin as a Therapy for Depression – Current Clinical Trials in the Use of Psilocybin for Depression

COMPASS and Usona are the main players working on psilocybin trials. It’s possible that the FDA will assign breakthrough therapy status to additional research institutes, but as it currently stands, COMPASS and Usona are the current two institutes engaged in the study of psilocybin as a treatment for significant depression. Let’s take a look at where they currently stand.



According to data from a phase 2b research study, therapy with the psychedelic substance psilocybin was related with a substantial decrease in depressive symptom intensity in individuals with treatment-resistant depression. In November of 2021, the findings were made public.

The 233 patients in the controlled, double-blind experiment made it the biggest psilocybin trial to date. Participants were given a single dosage of either 25mg, 10mg, or 1mg of psilocybin after discontinuing antidepressants prior to the start of the study. The change in Montgomery-Asberg Depression Rating Scale (MADRS) score was the study’s primary goal.

Understanding the Montgomery-Åsberg Depression Rating Scale (MADRS)

The Montgomery–Asberg Depression Rating Scale (also known as MADRS) is a ten-part diagnostic test used by psychiatrists to assess the severity of depression episodes in mood disorder patients. A higher MADRS score implies more severe depression, with a score of 0 to 6 for each component. The total score is a number between 0 and 60.

The following symptoms are included in the questionnaire 

  • Visible sadness
  • Reported sadness
  • Internal turmoil or tension
  • Lack of sleep
  • Lack of appetite
  • Difficulty concentrating
  • Lack of energy
  • Pessimistic beliefs and thoughts
  • Suicidal ideation

The following are typical cutoff points:

  • 0 to 6 – normal / no symptom
  • 7 to 19 – mild depression
  • 20 to 34 – significant depression
  • Over 34 – severe depression

The difference in MADRS total scores between the 25mg and 1mg groups at week three was -6.6 points, according to the COMPASS study’s findings; a statistically significant difference was detected between day two and week six.

Three weeks later, 36.7% of patients in the 25mg group had responded, compared to 17.7% in the 1mg group. Remission was obtained by 29.1% of patients in the 25mg group and 7.6% of individuals in the 1mg group at week three. At week twelve, 24.1% of patients in the 25mg group and 10.1% of patients in the 1mg group had a sustained response. At week three, no statistically significant change was seen when the 10mg dosage was compared to the 1mg dose. Clearly, there is some scientific evidence that microdosing magic mushrooms for psilocybin therapy of depression and mental disease might be quite helpful. In terms of adverse events, 179 patients reported at least one. Twelve individuals reported suicide conduct, purposeful self-injury, and suicidal ideation, among other significant side effects. The 25mg group had a higher rate of these than the 10mg or 1mg groups.

The CEO and co-founder of Compass Pathways, George Goldsmith, notably said that with this captivating data, “we will urgently progress our clinical development program and move closer to making this therapy accessible to patients in need if approved.”

The Food and Drug Administration (FDA) designated psilocybin as a Breakthrough Therapy for the treatment of major depressive disorder in October 2018. As we’ve already discussed in this article, breakthrough designation offers a faster path to approval. The findings of COMPASS are a good example of why breakthrough treatment status is so crucial for medical progress.

In the United States, psilocybin is currently classed as a Schedule I substance since the FDA has not cleared it for any medicinal use. With findings like these, it’s very possible that we might see that drug classification change in the near future.



In 2019, the US Food and Drug Administration (FDA) designated psilocybin as a Breakthrough Therapy for the treatment of major depressive illness. The Usona Institute, a nonprofit research center, was granted this status in order to begin clinical trials with patients suffering from MDD and psilocybin treatment.

The FDA’s Breakthrough Therapy Designation demonstrates the agency’s commitment to encouraging an efficient psilocybin development program in MDD. The designation of psilocybin as a Breakthrough Therapy for MDD by the Usona Institute acknowledges both the unmet medical need in this broad population and the potential for significant improvements over existing therapies, bolstering Usona’s mission to advance this revolutionary treatment paradigm toward new drug approval, according to the Usona Institute.

Previous studies have clearly demonstrated psilocybin’s amazing potential as a therapy for MDD patients, which Usona is now attempting to validate in its own clinical trials. The FDA’s appropriate recognition that MDD, not simply the considerably smaller treatment-resistant depression group, is an unmet medical need, and that the current studies show that psilocybin may give a significant therapeutic improvement over existing medications, is genuinely remarkable. These discussions will ensure that Usona and the FDA are united in pursuing the development program with accepted best practices, given the intricacy of psilocybin and the fact that Usona is breaking new territory.

The new status comes on the heels of the recent start of Usona’s Phase 2 clinical trial, PSIL201, which will enroll about 80 people across seven research sites across the United States. Several of the seven research locations are still looking for volunteers.

This is a big step forward for the nearly 17 million Americans who suffer with MDD. Despite the fact that there are multiple known MDD treatments, psilocybin has been designated as a Breakthrough Therapy because it may provide a clinically meaningful improvement over previous treatments. Psilocybin has the potential to create a new paradigm in which a short-acting substance causes substantial changes in consciousness and can lead to long-term remission of depressive symptoms. Depression is the biggest cause of disability in the world, impacting about 300 million people. This classification, which has such a broad potential impact, is a significant step forward in mental health research and for people suffering from depression.

The Usona Institute is a non-profit medical research organization (MRO) that performs and supports pre-clinical and clinical research to better understand the therapeutic benefits of psilocybin and other consciousness-expanding drugs. Its main goal is to cure depression and anxiety in those who have tried and failed to find relief and a better quality of life with conventional medical therapies.

We hope you have enjoyed this information! Don’t forget to take a look at our collection of Mushroom Spore Syringes and mushroom spores for sale at Shaman Mushroom Spores to start your microscopic research today.

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