By Kamal Choudhury and Christy Santhosh
April 24 (Reuters) – The U.S. health regulator on Friday moved to speed up the development of new treatments for serious mental illness by awarding the national priority vouchers to three companies, days after President Donald Trump signed an executive order.
The executive order, signed on April 18, directed the U.S. Food and Drug Administration to give the 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.
Compass Pathways has confirmed that it received a voucher for its candidate COMP360, a synthetic form of psilocybin for treatment-resistant depression.
Of the remaining two companies, one is studying psilocybin for major depressive disorder and another is studying methylone for post-traumatic stress disorder, the FDA said.
Usona Institute and Transcend Therapeutics are developing such treatments, respectively.
Usona Institute confirmed to Reuters that they have received a national priority voucher from the FDA, while Transcend Therapeutics did not respond to a request to confirm whether it was a recipient.
The Department of Health and Human Services also did not respond to a request to identify the companies involved.
Earlier this week, Compass CEO Kabir Nath told Reuters that the company aims to be “launch-ready by the end of this year.” On the executive order, Nath said it is “not going to be a huge acceleration for Compass, but it does offer some more momentum toward a potential approval.”
Compass shares were up about 2% in midday trading.
Mental illness remains widespread, affecting 23.4% of U.S. adults in 2024 and 17.6% of veterans in 2023, according to the National Alliance on Mental Illness.
Psychedelic treatments work primarily by activating proteins on the surface of nerve cells that regulate the brain’s ability to reorganize, form new connections and repair damaged circuits. Risks of psychedelic-assisted therapy include acute anxiety, panic and confusion during administration of the medicine.
Despite Trump’s vocal support for ibogaine, a psychoactive derived from a shrub native to Africa, the FDA did not include it in the list of drugs receiving priority vouchers. The agency, however, is allowing an early-stage clinical study of a derivative of ibogaine, developed by DemeRx NB, as a potential treatment for alcohol-use disorder.
Experts said the focus on psilocybin reflects its more advanced clinical profile. “Maybe ibogaine is just a year away from a similar position,” said Michael Thase, a professor of psychiatry at the University of Pennsylvania.
Others viewed the development in a more positive light.
“This is exceptionally fast action,” said Bryan Hubbard, CEO of Americans for Ibogaine, who attended Trump’s signing of the executive order. “Commissioner Markary and his team have walked their talk on accelerating the approval process. This is a good start.”
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.
But psilocybin has been studied more extensively than other psychedelic drugs, with research over the past decade, including at Johns Hopkins University and Imperial College London, showing it can significantly reduce symptoms of depression.
Ibogaine has been studied far less and carries a more troubled safety record.
(Reporting by Kamal Choudhury and Christy Santhosh in Bengaluru and Chris Prentice in New York; Editing by Shilpi Majumdar)
Comments