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COMPASS Pathways received Breakthrough Therapy designation in Autumn 2018 from the US Food and Drug Administration (FDA) for its psilocybin therapy to treat depression. COMPASS Pathways will run a large-scale psilocybin therapy clinical trial for treatment-resistant depression in Europe and North America in 2018-2019.
Psilocybin therapy uses psilocybin, the psychoactive ingredient in the psilocybin mushrooms, also known as “magic mushrooms”, and is given along with psychological support. In the UK and the US, Psilocybin therapy how shown promise in terms of efficacy and safety for depression treatment in academic studies.
COMPASS Pathways is making psilocybin available free of charge through the Medicines Chest programme to the European College of Neuropsychopharmacology (ECNP).