The US Food and Drug Administration (FDA), now considers psilocybin a “breakthrough treatment” for major depressive disorder (MDD), and has put it on the “fast track” for future clinical studies.

MDD effects more than 16 million people in the US and is the leading cause of disability in people between the age of 15 and 44, according to the Anxiety and Depression Association of America.

It is also estimated that around 322 million people globally live with some form of depression. But, now that scientists and researchers are discovering the healing potential of mushrooms, these numbers could see a massive decrease.

A “Breakthrough Therapy” designation means that a potential treatment priority review will be given by the FDA to further understand how it may treat certain disorders and illnesses.

The designation was granted after a request from the Usona Institute, a nonprofit medical research group that study and research psilocybin. They argue that there is an unmet medical need that could be filled via psilocybin’s potential to improve existing therapies.

Recent studies have shown that magic mushrooms can reduce severe depression and may even, “reset” the brains of people with depression without the side-effects linked with most man-made antidepressants.

Scientists are still unclear as to how exactly the chemical compound psilocybin may treat depression, but a study from the Beckley Foundation suggests that psilocybin may actually “reactivate” or connect certain regions of the brain and restore some neural capacity.

“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. What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” said Charles Raison, MD, director of Clinical and Translational Research at Usona.

Usona, at the moment is moving onto Phase 2 clinical trials “PSIL201” with 80 study participants across 7 U.S. locations, 2 of which are currently recruiting. 😉

The landmark study conducted by the Beckley/Imperial Research Programme has provided some of the first clinical evidence for the efficacy of psilocybin-assisted psychotherapy to treat depression, even in cases where all other treatments have failed.

The study gave oral psilocybin to 20 patients with depression that were resistant to past treatments, all of which previously tried at least 2 other treatments without success.

Participants had depression for an average of 18 years, with severity ranging from moderate to severe. Each patient were administered with two doses of psilocybin (10mg and 25mg) 7 days apart, followed by psychological support before, during, and after.

Results highlights, All patients showed reduction in their depression scores at week 1, with maximal effects seen at week 5. The drug was also well tolerated by all participants involved in this study, and no patients sought man-made antidepressant treatment within 5 weeks of the psilocybin treatment.

These results are extremely encouraging and confirm that psilocybin, needs further research into this area.