The Food and Drug Administration on April 24 said it will seek fast trials for three psychedelic drugs, including psilocybin, one week after President Donald Trump’s directive to accelerate access to psychedelic treatments for mental health conditions.
Three national priority vouchers are being issued, including two for psilocybin, the FDA said in a statement.
One of the companies receiving a voucher is developing psilocybin for depression that resists other treatments. Another has been developing psilocybin for major depressive disorder.
The third voucher is going to a company that has been testing methylone in post-traumatic stress disorder patients.
Trump on April 18 issued an order that directed health officials to establish a pathway to authorizing psychedelic drugs, saying they have shown potential in clinical trials against mental illness. Psychedelics can cause hallucinations and are currently banned in the United States.
Psilocybin is the active ingredient in mushrooms that are sometimes ingested for their hallucinogenic effects, while methylone can cause increased blood pressure and euphoria.
“Under President Trump’s leadership, we are accelerating the research, approval, and responsible access to promising mental health treatments—including psychedelic therapies like ibogaine—to confront our nation’s mental health crisis head-on, especially for our veterans,” Health Secretary Robert F. Kennedy Jr. said in a statement.
FDA Commissioner Dr. Marty Makary said, “These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions.”
The companies that received the vouchers were not identified by the FDA. The agency did not return a request for the company names.
The Usona Institute, a nonprofit, received one of the vouchers for psilocybin, a spokesperson told The Epoch Times in an email. The institute has been developing psilocybin for major depressive disorder treatment.
“Usona Institute is deeply grateful to the FDA and the Commissioner’s office for this recognition,” the spokesperson said.
Compass Pathways said in a statement that it was one of the companies. Compass has been developing synthetic psilocybin to treat treatment-resistant depression.
Kabir Nath, the CEO of Compass, said that phase 3 clinical trials have generated positive data. Nath said the voucher “is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science” of the drug, which is known as COMP360.
The FDA also said on April 24 that it would allow a clinical study of noribogaine hydrochloride, a derivative of the plant-based psychoactive compound ibogaine and a potential treatment for alcoholism.
DemeRx NB is developing noribogaine hydrochloride.
Regulators also said they will release final guidance “imminently” to other companies developing psychedelics, including guidance on carrying out studies and monitoring patients.