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The US FDA just granted a Breakthrough Therapy designation to a treatment now in clinical trials for the use of psilocybin mushrooms – magic mushrooms – as a therapy for treatment-resistant depression.
The FDA only classifies a drug as Breakthrough Therapy if the initial trial evidence shows that it may demonstrate a significant improvement over the treatments that are available. If a drug is designated as such, the FDA will grant priority and expedite the clinical development process.
That is really good news for the 100 million people worldwide that suffer from treatment-resistant depression. According to The American Psychiatric Association, depression is a common and serious medical illness that negatively affects the way people think and act. It can lead to physical and emotional problems and the inability to function at home or on the job. Taking antidepressants or undergoing psychological counseling helps combat depression, but, for some people, these treatments are not enough. Now there is potential help for them.
This ground-breaking research was developed by Compass Pathways, a life science company that is dedicated to accelerating patient access to new innovations in the treatment of mental health.
Psilocybin, the psychoactive compound in magic mushrooms, has been researched for many years by teams in the US, UK, and Switzerland. In the UK, the Medical Research Council backed the proof-of-concept study of Psilocybin for treatment-resistant depression at Imperial College London in 2015. Compass Pathways is now running the first large-scale clinical trial.
The FDA approval came less than a month after Johns Hopkins published clinical trial results about Psilocybin suggesting a change of classification from a Schedule I drug, a drug with no known medical potential, to a schedule IV drug like the classification of prescription sleep aids but with greater safety controls. The phase III clinical trials must be completed before the FDA can be petitioned to reclassify it and that is at least five years away.
George Goldsmith, the executive chairman of Compass Pathways said, "We are excited to be taking this work forward with our clinical trial on psilocybin therapy for treatment-resistant depression. The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible."
That’s should be a huge glimpse of hope for people dealing with depression.
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