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FDA announces Psilocybin as a "breakthrough" method for combating treatment-resistant depression.

The U.S. Food and Drug Administration has recently granted the second pioneering psilocybin therapy authorization to the Usona Institute, a medical research institute based in Wisconsin that conducts and supports preclinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. They have been approved to utilize psilocybin in the treatment of major depressive disorder (MDD). This is the second public institution, the first being Compass Pathways (in Oct. 2018) to be granted permission to apply this powerful psychoactive substance in a controlled therapeutic setting.

More than 17 million people in the United States suffer from MDD, which is defined as severe depression lasting over 2 weeks. Through its new classification under the "breakthrough therapy" designation, psilocybin is recognized as possibly offering a statistically significant improvement over existing MDD treatments. The "breakthrough therapy" designation is usually reserved for drugs that show immense improvement over rival treatment methods, and serves to greatly accelerate the process of pharmacological research and development.


This new designation follows the recent launch of Usona's phase 2 clinical trial (PSIL201), in which the institute will recruit roughly 80 patients at seven study sites around the United States. The study will assess the safety and efficacy of a single dose of psilocybin in comparison with placebo in patients aged 21 to 65 years who have MDD. More information and a signup form for this study can be found here


Taken from the Institutes initial publication of psilocybin's new status, Charles Raison, MD, Usona's director of clinical and translational research, states "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," In the same publication Raison also states "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,"


Statistically 1 out of 3 drugs given the "breakthrough therapy" designation complete the rigorous clinical trial process, Usona's PSIL201 is set to be complete in 2021, at which point they will proceed to the third and final clinical testing phase. While psilocybin is still years away from a marketable depression treatment, it is moving at lightning speed compared to the average 10 years it takes for a pharmaceutical company to develop and test new drugs.

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