April 24 (Reuters) – The U.S. Food and Drug Administration said on Friday it is taking steps to speed up the development of new treatments for serious mental illness such as depression, following an executive order signed by President Donald Trump last week.
The executive order directed the FDA to give commissioner’s national priority vouchers to psychedelic drugs that have the “breakthrough therapy” tag, potentially cutting the review time to one to two months from the usual six to 10 months.
About 23.4% of U.S. adults experienced mental illness in 2024, while 17.6% of U.S. veterans did so in 2023, according to the National Alliance on Mental Illness.
The health regulator said it would issue national priority vouchers to three companies developing psychedelic treatments.
Of the three companies, two are studying psilocybin for treatment-resistant depression and major depressive disorder, and another is studying methylone for post-traumatic stress disorder.
“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,” FDA Commissioner Marty Makary said in a statement.
While the FDA did not disclose the names of the companies, Compass Pathways is developing a synthetic form of psilocybin for treatment-resistant depression, Usona Institute is studying psilocybin for major depressive disorder and Transcend Therapeutics is developing methylone as a potential treatment for PTSD.
Compass, Usona and Transcend did not immediately reply to Reuters’ requests for comment.
Ibogaine is the only psychedelic mentioned in the executive order, though LSD, MDMA and psilocybin are also being studied in large U.S. trials for various mental health conditions.
Both psilocybin and ibogaine are listed as Schedule I drugs, meaning they currently have no accepted medical use and a high potential for abuse, according to the Drug Enforcement Administration.
The FDA also cleared the way for the first human trial in the United States of noribogaine, a derivative of ibogaine. Ibogaine is derived from a shrub native to Africa.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar)
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