Under a new designation by the US Food and Drug Administration (FDA), psilocybin – a hallucinogenic chemical found in psychedelic mushrooms – is now considered a “breakthrough treatment” for major depressive disorder (MDD), putting it on the “fast track” for future clinical studies.
A Breakthrough Therapy designation grants a potential treatment priority review by the FDA to further understanding of how it may treat certain disorders and illnesses. The designation was granted after a request from the Usona Institute, a nonprofit medical research group conducting research on psilocybin, in recognition that there is an unmet medical need that may be fulfilled through psilocybin’s potential to improve existing therapies.
Characterized by a persistent feeling of sadness or loss of interest, MDD is a mood disorder that affects how a person may think, feel, and behave – all of which can trickle into everyday activities, according to the Mayo Clinic. MDD impacts more than 16 million people in the US and is the leading cause of disability in those between the ages of 15 and 44, according to the Anxiety and Depression Association of America. It is estimated that 322 million people globally live with some type of depression.
Previous studies have shown that magic mushrooms can ease severe depression and may “reset” the brains of people with depression without the emotional numbing associated with some traditional antidepressants. It is unclear how exactly the chemical compound may treat depression, but a study from the Beckley Foundation suggests that psilocybin may reactivate or connect certain regions of the brain and their 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, in a statement.
“Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices,” he added.
Usona is currently moving into its Phase 2 clinical trial PSIL201 with 80 study participants across seven US study sites, two of which are currently recruiting while the others aim to be active at the beginning of the new year.
[H/T: Live Science]