Psilocybin advances in U.S. therapy as FDA speeds review, but access is costly

Psilocybin has pulled ahead in efforts to commercialize psychedelic medicine in the United States, with the Food and Drug Administration moving up its review of a Compass Pathways treatment by nine to 12 months, the applicant said. Compass hopes to receive approval before the end of the year.

The drug is legally available for therapy in three states. The acceleration has injected fresh optimism into a nascent field that was rattled by the F.D.A.’s 2024 rejection of MDMA‑assisted therapy. The article said the move was among the first concrete signs that the Trump administration is recognizing psychedelic medicine as a potential therapy tool.

New Mexico joined Colorado and Oregon last year in offering legal psilocybin therapy, and lawmakers in about a dozen other states are considering easing restrictions or funding research. Oregon’s rollout, as the first state to legalize psilocybin therapy, has highlighted practical obstacles.

High operating costs — including annual licensing fees of about $10,000, staffing rules that require two people on site, zoning limits and a county opt‑out provision — have contributed to session prices of roughly $850 to $3,000 and to the closing of about a third of the state’s 36 licensed service centers.

Key Topics

Health, Psilocybin Therapy, Compass Pathways, Fda, Oregon, Oregon Health Authority