In August 2017, the Food & Drug Administration (FDA) designated MDMA a "breakthrough therapy" for the treatment of post-traumatic stress disorder (PTSD). One year later, the FDA has done the same for psilocybin (the psychoactive ingredient in psychedelic mushrooms) as a therapy for treatment-resistant depression. In both cases, the FDA bestowed the designation on specific therapies, with London-based COMPASS Pathways earning breakthrough status for its psilocybin therapy.
"This is great news for patients," said George Goldsmith, the company's Executive Chairman, in a press statement. "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."
A Breakthrough Therapy designation means that preliminary clinical evidence suggests a particular therapy produces substantial improvement compared to therapies currently available. Now with FDA support, COMPASS Pathways will run the "first large-scale psilocybin therapy clinical trial for treatment-resistant depression" in Europe and North America.
An FDA-approved study conducted this past summer by Dr. Robin Carhart-Harris, Head of the Psychedelic Research Group at Imperial College London, helped pave the way for the designation.
"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 treatment for treatment-resistant depression," he explained. "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-centre trial."
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