“Breakthrough” Psilocybin compound fast-tracked by FDA

November 28, 2019

FDA gives psilocybin a major boost: The process of having a new drug be approved is understandably slow but also quite frustrating, in rare form, the FDA (US Food & Drug Administration) has granted a clinical trial on Psilocybin, a hallucinogenic substance found in magic mushrooms and truffles alike, “breakthrough therapy” designation for the second time this year, allowing a normally snail-paced process to be significantly sped up.

Psilocybin trials take place everywhere

Several clinical trials and companies across the US are currently running tests on psilocybin. Earlier this year a trial ran by Compass Pathways, “a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health” received the ‘breakthrough therapy’ designation for their on-going innovative therapy revolving around psilocybin. Referred to as ‘psilocybin therapy’ the goal of the trial is to find out psilocybin’s capabilities in treating severe cases of depression where the patient has not responded to other forms of treatment. Essentially a last resort option for patients.

New trial “breakthrough therapy”!

The trial in question today is ran by the Wisconsin-housed Usona Institute, a “non-profit medical research organization” that focuses on psilocybin based therapies and treatments. Also granted the ‘breakthrough therapy’ designation by the FDA, their trial contains 80 participants across the US suffering from MDD (Major Depressive Disorder, the clinical term for depression) being treated with a single dose of psilocybin. The focus of the trial being to study “psilocybin as a treatment for major depressive disorder”.

A giant leap for mankind?

However there is a huge difference between this trial and the trial ran earlier in the year by COMPASS and its significance should not be understated. Usona’s trial is for the general use of psilocybin as a treatment for depression, a first choice or path of treatment rather than it being a last resort option as shown in the earlier trials by COMPASS. This trial is basically exploring the efficacy of psilocybin as a replacement or alternative to most typical forms of antidepressants such as SSRI’s.

How does a clinical trial get “breakthrough therapy” designation?

According to the FDA, this designation is available on request to any clinical trial, providing the trial can produce preliminary evidence that the drug in question poses a significant improvement over already existing therapies.

What’s good for one is good for all!

This is an exciting time for all who have shared in the experiences of psilocybin, from recreational users to self-medicators, namely through magic mushrooms and truffles, and know of it’s great potential both medically and spiritually. Having psilocybin reach the forefront of current therapy could be a major step forward for humanity as the research surrounding psilocybin is ever opening new doors and answering old questions. Clinical trials like those mentioned above strengthen our fervour as a supplier of magic mushrooms and truffles to all who seek to endeavour!