Virginia prepares for potential FDA approval of psilocybin
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FDA-approved psilocybin — the psychedelic compound in so-called "magic mushrooms" — could be on the horizon, and some Virginia providers are already gearing up to deliver it if approved.
Why it matters: Virginia has laid the groundwork for the treatment to become available if it wins federal approval, and a company preparing for a potential rollout tells Axios that Richmond is in its expansion plans.
Driving the news: The FDA held a public hearing Monday on how psychedelic treatments could safely move into mainstream health care, as the Trump administration pushes regulators to accelerate research and review of psychedelic drugs for serious mental health conditions.
- The debate boiled down to safety versus access: who should supervise patients, how much training they need and whether strict rules could make treatment too expensive or hard to find.
Catch up quick: Psilocybin remains a federally controlled drug. But Virginia lawmakers anticipated approval this year, passing a law that creates a path for an FDA-approved version to become legal once regulators change its controlled-substance status.
- At the front of the pack is Compass Pathways' COMP360, a psilocybin treatment for people with treatment-resistant depression. Its FDA application is partly under review.
- Journey Clinical — which is working with Compass on how the treatment could reach patients — tells Axios it expects approval by year's end and a potential rollout in early 2027.
- But that's Journey's projection, not an FDA timeline.
How it works: This wouldn't be a prescription you pick up at the pharmacy.
- Patients would be screened and receive COMP360 at a treatment site under supervision for several hours.
Zoom in: Journey — which partners with therapists, including 100 in Virginia — is using an existing network for another depression treatment to prepare for what could come next.
- The company offers Spravato, an FDA-approved, ketamine-derived nasal spray for hard-to-treat depression given at certified medical facilities.
- Co-founder and CEO Myriam Barthes tells Axios the company has been mapping out a potential psilocybin rollout, from identifying eligible patients and navigating insurance approval to handling appointment logistics.
- If COMP360 is approved, Barthes says, Journey's existing Spravato sites would be first in line to offer it before expanding elsewhere.
Between the lines: Journey's only Virginia Spravato site is in Charlottesville. But executive Nora Studholme tells Axios that Richmond is "absolutely" in the company's expansion plans.
Yes, but: FDA approval wouldn't mean Virginians could get psilocybin right away.
- The DEA would first have to change the drug's federal classification before Virginia's Board of Pharmacy could act, the state Department of Health Professions tells Axios.
- Once the board votes, the change generally takes three to four months to take effect, DHP says.
What's next: Compass expects to finish its FDA application by year's end, setting up a potential decision within months.
Go deeper: FDA creates path for psychedelic drug trials