Compass Pathways Seeks FDA Approval for Psilocybin in Treatment-Resistant Depression

Compass Pathways has submitted a New Drug Application (NDA) to the U.S. FDA for COMP360, its synthetic psilocybin formulation, to treat treatment-resistant depression (TRD). If approved, COMP360 would be the first classic psychedelic to receive FDA clearance, marking a significant advancement in psychedelic-assisted therapies. This could offer a new treatment option for patients who have not responded to conventional depression treatments.