FDA gives breakthrough designation for psychedelic treatment

The FDA granted Breakthrough Therapy Designation for a psychedelic-based adjunctive therapy for major depressive disorder, according to a press release. The designation is intended to expedite development and review of treatments that show substantial improvement over existing options. The therapy is being developed by a clinical-stage biopharmaceutical company focused on next-generation psychedelic treatments for mental health.

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Abstract

A clinical‐stage biopharmaceutical company that officials said is committed to revolutionizing mental health care by developing new and innovative next‐generation psychedelic‐based treatment options, announced last week that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for an adjunctive psychedelic‐based therapy for the treatment of major depressive disorder (MDD), according to the press release news outlet, Businesswire.