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Compass Pathways' Psilocybin Therapy Receives FDA's Breakthrough Therapy Designation for Treatment-Resistant Depression

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Compass Pathways' Psilocybin Therapy Receives FDA's Breakthrough Therapy Designation for Treatment-Resistant Depression

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  • The FDA’s BT designation follows clinical study assessing Psilocybin in 19 patients with treatment resistant depression- conducted at Imperial College London in 2015
  • FDA’s BT designation is granted to the drugs showing substantial improvement over currently available therapy in serious or life-threatening conditions on at least one clinically significant endpoint with benefits of Priority Review and accelerated approval
  • Psilocybin is a serotonin 2 receptor agonist- being evaluated in a clinical study for treatment-resistant depression in EU and North America

Ref: Compass Pathway | Image: Compass Pathway

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