The FDA has granted Breakthrough Therapy Designation to Psilocybin (i.e. magic mushrooms) for the second time in a year. The new attribution is supposed to speed up research for treatments that have a lot of potential.
The first designation was granted by the FDA to COMPASS Pathways an organization that specializes in helping people with treatment resistant depression. They are now running their second, large multicenter trial in the US, UK and Europe.
However, the renewed designation will accelerate a seven site phase 2 trial currently being run by the USONA institute, out of the United States of America.
Charles Raison Usona’s director of clinical and translational research was quoted saying:
“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD (Major Depressive Disorder) 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.”
USONA will enroll 80 subjects, who will either receive psilocybin or a placebo containing niacin. The study will also include a psychotherapy session before the active psychedelic dose, and afterward in order to help the participants integrate the new experience.
Silo Wellness has developed a magic mushroom nasal spray in Jamaica – where psilocybin is legal for ‘microdosing’.
It passes the gut, and goes directly in to the bloodstream through the nasal mucus membrane which prevents the patient from feeling nauseous as is commonly reported when taking psilocybin.
Board Advisor and Silo Wellness investor Becky Rotterman, a Missouri pharmacist, stated: “Many psilocybin patients, particularly women, complain of upset stomach or vomiting when taking high-doses of mushrooms.
“We want to bring this wonderful natural medicine first to Oregon and then the flyover states – to those who would be afraid to eat a handful of fungi and who feel more comfortable seeing their medicine in a familiar delivery modality, such as a metered-dose nasal spray.”
If the legalization of cannabis continues to prove both profitable for the government and beneficial to the population then other psychedellics will become next logical step in the process of decriminalization. When that occurs, companies like Silo Wellness, who are already on the forefront, will be ready to roll out products that are more familiar to the average person with no experience ingesting psychedellic substances.