FDA Fast-Tracks Psilocybin and Methylone With New Priority Review Vouchers

A White House executive order signed in April 2026 authorized the FDA Commissioner to issue National Priority Vouchers for psychedelic compounds that have received Breakthrough Therapy designation — cutting review timelines from the typical 6 to 12 months down to 1 to 2 months.

Three companies immediately received vouchers: Usona Institute (psilocybin for major depressive disorder), Helus Pharma (psilocin, the active form psilocybin converts to in the body, also for MDD), and Transcend Therapeutics (methylone, a compound similar to MDMA, for severe PTSD). Methylone received breakthrough designation after a Phase 2 trial showed “rapid, robust, and durable improvements” in participants with severe PTSD. Transcend recently initiated Phase 3 trials.

The acceleration comes after Lykos Therapeutics (formerly MAPS PBC) received an FDA Complete Response Letter for MDMA-assisted therapy for PTSD in 2024, citing concerns about trial design and the difficulty of blinding participants to an active psychedelic. The new pathway suggests the administration has chosen to move forward with the category through a different regulatory mechanism rather than relitigating the Lykos decision.

Psilocybin, MDMA-class compounds, and ibogaine are each now in late-stage clinical development, with approval for at least one indication potentially achievable within 1 to 3 years. Texas has passed legislation actively encouraging FDA to advance approval.

Why This Matters for People in Recovery

Approximately 48.5 million Americans have a substance use disorder, and many also carry untreated PTSD and treatment-resistant depression — conditions that both complicate recovery and increase relapse risk. Psychedelic-assisted therapy, if approved, would represent the first genuinely new mechanism for treating these conditions in decades. Rize Recovery tracks emerging treatment options as they move toward availability. Learn more about treatment options.