The Food and Drug Administration on Friday granted a quick review of three experimental psychedelic drugs meant to treat major depression and post-traumatic stress disorder.
It’s the latest move by the Trump administration signaling a shift in policy toward treatments that also give users a high — coming a day after the Justice Department said it would ease restrictions on state-licensed medical marijuana.
UK-based biotech company Compass Pathways said Friday it has received an expedited review for its experimental form of synthetic psilocybin for treatment-resistant depression. In a press release the company cited two large, phase 3 studies that had "generated positive data."
Usona Institute, headquartered in Wisconsin, also said it’s received a voucher for its work with psilocybin to treat major depressive disorder. In an email, a Usona spokesperson said the company expects the review process to last one to two months after it submits its application. “The voucher expedites the timeline only; it does not alter scientific or regulatory standards,” the spokesperson wrote.
New York-based Transcend Therapeutics has also been granted a priority review voucher for its experimental drug methylone for PTSD, Blake Mandell, the company's chief executive officer, said.
The Trump administration declined to confirm which pharmaceutical companies have been issued priority vouchers for what’s usually a lengthy, monthslong FDA review.
The push for an increase in research and access to alternative therapies for mental health problems, specifically psychedelics, has been led in part by war veterans.
“There’s a battle still raging in their mind that we don’t fully understand biochemically,” FDA Commissioner Marty Makary said. “When you see something that looks promising for a community that is suffering with mental health illness, despair and suicidal ideation, you can’t help but recognize that.”
On Monday, Makary told NBC News that with the priority voucher program, the agency could potentially approve the first psychedelic drug by the end of summer.
The program began in June last year. It’s intended as an effort to speed up the review process for drugs or products deemed urgently needed — and can cut the time it takes for FDA approval from a year to just a few months.
Critics of the program say it was put in place without seeking input from Congress, and could ultimately undermine trust in the FDA’s regulatory process by opening the door for companies to make financial contributions to the administration in an attempt to secure such a voucher.
The road to approval for any drug can be bumpy. In 2024, the FDA rejected MDMA, a psychedelic drug commonly known as ecstasy, for treating PTSD, despite intense political pressure from veterans groups to approve it. The agency told the drug company Lykos Therapeutics that there wasn’t enough evidence that the therapy was safe and effective. An independent advisory committee to the FDA highlighted serious concerns with the research, including poor study design, allegations of sexual misconduct during one of the trials and the potential for health risks after taking the drug, including heart problems and abuse.
Research into psychedelics has been limited. The drugs are illegal in the United States and any real-world effects have been anecdotal and based on usage in other countries.
Last weekend, President Donald Trump signed an executive order meant to spur U.S.-led research into psychedelics.
Experts who study such drugs welcomed rigorous, scientific scrutiny.
Dr. Peg Nopoulos, chair of the University of Iowa’s psychiatry department, said she was “happy to see that the wheels are being greased” on such research. She has led research comparing psilocybin to ketamine for alcohol use disorder. Both can give users a psychedelic experience.
Psychedelics are “powerful drugs. I’ve seen them save lives,” Nopoulos said. “However, I’m a scientist, and there’s no way we can approve a drug without understanding who’s going to benefit from it, who’s not going to benefit from it and what the risks are.”
“The science behind it has to be rock-solid,” she said.
Friday’s action also permits researchers to study a form of the psychedelic ibogaine for the first time within the U.S. Miami-based drug company DemeRx NB will research a derivative of the drug, noribogaine hydrochloride, as a potential treatment for alcohol use disorder. Nearly 28 million — 1 in 10 — Americans have alcohol use disorder, according to the National Institute on Alcohol Abuse and Alcoholism.
Noribogaine reportedly does not induce the intense, hourslong and sometimes emotionally upsetting high associated with ibogaine.
