FDA to fast-track review of three psychedelic therapies for depression and PTSD
The FDA announced it will accelerate the review of psychedelic drugs from three companies as part of a broader initiative to increase access to mental-health treatments.
Compass Pathways will receive a priority review voucher for its psilocybin candidate aimed at treatment-resistant depression. Usona Institute's similar psilocybin product for major depressive disorder also qualifies for the voucher.
Transcend Therapeutics will get a voucher for its MDMA-like therapy targeting post-traumatic stress disorder. The accelerated timelines are intended to bring these experimental therapies to patients more quickly.
The move reflects the current administration's emphasis on expanding options for mental-health care, though the drugs remain under investigation and have not yet received approval.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: FDA to speed up review of three psychedelics as mental health treatments”
read at STAT ↗
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