Agency issues priority vouchers, clears new clinical research, and advances guidance to support treatments for depression, PTSD, and substance use disorders
President Trump on April 18 issued an Executive Order directing the U.S. Department of Health and Human Services to accelerate access to treatments for patients with serious mental illness, including devastating, complex, and treatment-resistant conditions.
Building on this directive, the U.S. Food and Drug Administration today announced a series of regulatory actions to support the development of serotonin-2A agonists and related products, a class of perception-altering psychedelic medications.
“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,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “The FDA will prioritize therapies with Breakthrough Therapy designation, where early evidence shows meaningful improvement over existing options for serious mental illness.”
“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,” said FDA Commissioner Marty Makary, M.D., M.P.H. “As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.”
The FDA is issuing national priority vouchers to three companies studying:
- Psilocybin for treatment-resistant depression.
- Psilocybin for major depressive disorder.
- Methylone for post-traumatic stress disorder (PTSD).
In addition, the agency is allowing an early phase clinical study of noribogaine hydrochloride to move forward following an Investigational New Drug (IND) submission. The sponsor is investigating noribogaine as a potential treatment for alcohol use disorder, a condition with high relapse rates and limited treatment options. This is the first instance in which the FDA has allowed a clinical study in the U.S. of a derivative of ibogaine, a psychoactive indole alkaloid derived from the African Tabernanthe iboga shrub. This decision allows the company developing the novel drug, DemeRx NB, to begin a phase I clinical study of the drug in a closely monitored clinical setting in the United States.
The FDA’s decision allows the study to proceed and does not mean the drug has been approved or found to be safe or effective. The agency will continue to review data as it becomes available and support efforts to develop new treatments for alcohol use disorder and other mental health conditions.
Finally, the FDA intends to release final guidance imminently to provide recommendations to sponsors developing these products. Designing clinical trials to evaluate serotonin-2A agonists and related products presents unique scientific and methodological challenges. The final guidance reflects input from public comments and outlines foundational considerations for sponsors, including recommendations related to study design, data collection and generation, patient monitoring and conducting adequate and well-controlled clinical investigations.
“There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat,” said Tracy Beth Hoeg, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research. “At the FDA we are showing our support of investigating the safety and efficacy of this class of drugs through today’s actions.”