FDA Grants Quick Review For 3 Psychedelic Drug Trials
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An anonymous reader quotes a report from NBC News: 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. "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." Makary told NBC News that with the priority voucher program, the agency could potentially approve the first psychedelic drug by the end of summer.
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