Mushrooms got the key for treatment-resistant depression. Psilocybin, the active ingredient in mushrooms, bagged the Breakthrough Therapy designation for treatment-resistant depression(TRD) from the Food and Drug Administration (FDA).
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 programme to ensure smooth operations.
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The designation was granted to COMPASS Pathways, a life sciences company investigating psilocybin in a Phase 2b trial involving 216 patients at multiple sites across Europe and North America.
COMPASS Pathways is now running the first large-scale psilocybin therapy clinical trial for TRD, which will take place in Europe and North America over the next year or so.
George Goldsmith, Executive Chairman, COMPASS Pathways, said, “This is great news for patients. 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 from depression as quickly as possible.”
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Dr. Robin Carhart-Harris, Head of the Psychedelic Research Group, Imperial College London, said, “In our 2015 study, we provided psilocybin to 19 patients in a clinical setting, coupled with psychological support, and found promising signals of efficacy and safety as the treatment for TRD. The Breakthrough Therapy designation is a strong endorsement for the potential of psilocybin therapy. We look forward to learning more as further clinical studies are carried out, by our team at Imperial College as well as in COMPASS’s multi-center trial.”
Treatment-resistant depression is a huge unmet need, affecting 100 million people around the world who do not respond to existing treatments. Depression is one of the fastest growing health problems faced today, and the leading cause of ill-health and disability worldwide. The Breakthrough Therapy designation for psilocybin therapy highlights the importance of supporting early research that can be translated into clinically meaningful outcomes.