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. <\/p>\n
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It\u2019s the latest move by the Trump administration signaling a shift in policy toward treatments that also give users a high \u2014 coming a day after the Justice Department said it would ease restrictions on state-licensed medical marijuana<\/a>. <\/p>\n UK-based biotech company Compass Pathways<\/a> said Friday it has received an expedited review for its experimental form of synthetic psilocybin for treatment-resistant depression<\/a>. In a press release the company cited two large, phase 3 studies that had “generated positive data.” <\/p>\n Usona Institute, headquartered in Wisconsin, also said it\u2019s 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. \u201cThe voucher expedites the timeline only; it does not alter scientific or regulatory standards,\u201d the spokesperson wrote. <\/p>\n New York-based Transcend \u2060Therapeutics has also been granted a priority review voucher for its experimental drug methylone for PTSD, Blake Mandell, the company’s chief executive officer, said. <\/p>\n The Trump administration declined to confirm which pharmaceutical companies have been issued priority vouchers for what\u2019s usually a lengthy, monthslong FDA review. <\/p>\n 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.<\/p>\n \u201cThere\u2019s a battle still raging in their mind that we don\u2019t fully understand biochemically,\u201d FDA Commissioner Marty Makary said. \u201cWhen you see something that looks promising for a community that is suffering with mental health illness, despair and suicidal ideation, you can\u2019t help but recognize that.\u201d<\/p>\n 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.<\/p>\n The program began in June last year. It\u2019s intended as an effort to speed up the review process for drugs or products deemed urgently needed \u2014 and can cut the time it takes for FDA approval from a year to just a few months. <\/p>\n Critics of the program<\/a> say it was put in place without seeking input from Congress, and could ultimately undermine trust in the FDA\u2019s regulatory process by opening the door for companies to make financial contributions to the administration in an attempt to secure such a voucher. <\/p>\n The road to approval for any drug can be bumpy. In 2024, the FDA rejected MDMA<\/a>, a psychedelic drug commonly known as ecstasy, for treating PTSD, despite intense political pressure from veterans groups<\/a> to approve it. The agency told the drug company Lykos Therapeutics that there wasn\u2019t 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. <\/p>\n 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. <\/p>\n Last weekend, President Donald Trump signed an executive order meant to spur U.S.-led research into psychedelics. <\/p>\n Experts who study such drugs welcomed rigorous, scientific scrutiny.<\/p>\n Dr. Peg Nopoulos, chair of the University of Iowa\u2019s psychiatry department, said she was \u201chappy to see that the wheels are being greased\u201d on such research. She has led research comparing psilocybin to ketamine for alcohol use disorder. Both can give users a psychedelic experience. <\/p>\n Psychedelics are \u201cpowerful drugs. I\u2019ve seen them save lives,\u201d Nopoulos said. \u201cHowever, I\u2019m a scientist, and there\u2019s no way we can approve a drug without understanding who\u2019s going to benefit from it, who\u2019s not going to benefit from it and what the risks are.\u201d<\/p>\n \u201cThe science behind it has to be rock-solid,\u201d she said. <\/p>\n Friday\u2019s action also permits researchers to study a form of the psychedelic ibogaine<\/a> 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 \u2014 1 in 10 \u2014 Americans have alcohol use disorder, according to the National Institute on Alcohol Abuse and Alcoholism<\/a>.<\/p>\n Noribogaine reportedly does not induce the intense, hourslong and sometimes emotionally upsetting high associated with ibogaine. <\/p>\n","protected":false},"excerpt":{"rendered":"The Food and Drug Administration on Friday granted a quick review of three experimental psychedelic drugs meant to…\n","protected":false},"author":2,"featured_media":551098,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42],"tags":[102,6591,56,54,55],"class_list":["post-551097","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-medication","tag-uk","tag-united-kingdom","tag-unitedkingdom"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/551097","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/comments?post=551097"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/551097\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/551098"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=551097"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=551097"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=551097"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"\"\/](\"https:\/\/www.newsbeep.com\/uk\/wp-content\/uploads\/2026\/04\/1776884749929_now_daily_a_makary_ibogaine_fda_260422_S3_1920x1080-5yp9en.jpg\")
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