FDA Gives Psilocybin Breakthrough Therapy Designation for TRD

The US Food and Drug Administration (FDA) has granted breakthrough designation for psilocybin-assisted therapy.

Early results of COMPASS Pathways clinical trials are showing psilocybin works substantially better than conventional TRD drugs. As a result, the FDA has given breakthrough designation for psilocybin-assisted therapy. When a drug receives breakthrough therapy designation, the FDA works to expedite the development and review of the drug so it can get to patients as soon as possible. The designation is considered for drugs used to treat serious or life-threatening conditions. The FDA grants or denies the request for breakthrough therapy designation within 60 days of receiving the supporting clinical evidence from the drug sponsor.