FDA Accelerates Psychedelic Drug Review with Priority Review Vouchers for Compass, Usona and Transcend in Mental Health Push
- Food and Drug Administration has granted priority review vouchers to three companies developing psychedelic-based medicines for mental health conditions, accelerating the regulatory pathway for potential new treatments.
- The vouchers were awarded to Compass Pathways for its synthetic psilocybin formulation targeting treatment-resistant depression, to the Usona Institute for its psilocybin-based medicine for major depressive disorder and...
- This action falls under the FDA Commissioner’s National Priority Voucher pilot program, launched the previous year to fast-track review for certain drugs and biological products seeking approval, potentially...
The U.S. Food and Drug Administration has granted priority review vouchers to three companies developing psychedelic-based medicines for mental health conditions, accelerating the regulatory pathway for potential new treatments.
The vouchers were awarded to Compass Pathways for its synthetic psilocybin formulation targeting treatment-resistant depression, to the Usona Institute for its psilocybin-based medicine for major depressive disorder and to Transcend Therapeutics for its MDMA-like compound, methylone, intended for post-traumatic stress disorder.
This action falls under the FDA Commissioner’s National Priority Voucher pilot program, launched the previous year to fast-track review for certain drugs and biological products seeking approval, potentially reducing the time required for these treatments to reach patients.