The US Food and Drug Administration has granted a “Breakthrough Therapy” designation to a treatment that uses psychedelic mushrooms as a therapy for treatment-resistant depression.
The magic ingredient in magic mushrooms has certainly come a long way in a short time. The FDA designates a drug as a Breakthrough Therapy if preliminary clinical evidence shows that it may demonstrate substantial improvement over available therapy. Breakthrough Therapies are supported by the FDA throughout the clinical development program to ensure as efficient a process as possible.
The treatment was developed by Compass Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health.
