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FDA Grants Quick Review For 3 Psychedelic Drug Trials 52

Posted by BeauHD from the what-to-expect dept.
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.

FDA Grants Quick Review For 3 Psychedelic Drug Trials More | Reply

FDA Grants Quick Review For 3 Psychedelic Drug Trials

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  • They couldn't get a patent on it and make it cost hundreds of dollars unless it is.

    Where growing mushrooms, anyone can do.

    • Maybe they can produce it faster that way? It could also be due to concerns about contamination - if another fungal spore gets in the mix, it can kill people.

      If it makes you feel better, industrial production of vitamin-C is done entirely with mold.

      • Re:Of course the psilocybin is synthetic (Score:4)

        by ArchieBunker ( 132337 ) on Wednesday April 29, 2026 @09:09AM (#66118170)

        It's 2026. Given the option of a mega dollar patented synthetic drug or something that grows for free in cow shit, I know what they'll pick.

        The grocery store sells mushrooms without the fear or anyone dying.

        • No, you assume you know. Without, apparently, knowing that psilocybin is psilocybin regardless of how it was produced. They can patent a process to synthesize it but won't use it unless it is more efficient than just growing and processing mushrooms. Which, they will do if it is the cheaper option.

          Cynicism must be bounded by reason; else it is just foolish pessimism.

      • Also guarantee the dosage, for example I see jimpson weed growing all over the place which contains scopolamine but I don't dare try to use it because I have no idea how much is a moderate dosage, taken in small amounts it is good for calming the nerves and relieves nausia but too much of a dose causes nausia and a puts a person into a hypnotic trance like state, so it is not any good if you can not find the correct dose to use
        • I used to buy it for seasickness and while it did help some of my crew when needed, even the patches from the pharmacy could have undesired side effects at their carefully calibrated dose. NFW would I be eating Jimson Weed to solve motion sickness.

  • 1. When were you born?
    2. What music magazines were on the newsstands when there was a new album out?
    3. You didn't listen to music? At all? Go to #5.
    4. Who was the president then?
    5. Just go, man.

  • I dunno, that seems like a clueless thing to say. We're talking about psychedelics, here. They certainly do interesting things to your mind but, doing acid just doesn't seem remotely similar to smoking a joint or shooting up in search of the warm fuzzy-buzzies that constitute a "high". Psychedelics are not recreational in the same sense.

  • Oh, good. (Score:5, Interesting)

    by sabbede ( 2678435 ) on Wednesday April 29, 2026 @08:46AM (#66118128)
    My nephew has pretty severe PTSD from his time as a sniper in Afghanistan. The results that have come from experimental treatments with psylocibin and other psychedelics are impressive. This could save his life.

  • I think RFK and Trump are deranged incompetent lunatics, but it is pretty clear FDA staff have an emotional and cultural resistance to psychedlics as treatment.

    • Emotion and culture have nothing to do with it. The government studied psychedelics extensively in MK-ULTRA, and when they found out they usually do very much the opposite of what they wanted, they decided that we couldn't have them without a huge fuss and making sure dosage is controlled to have as subtle an effect as possible. You either get barely half of a nothing or you get blackout, no talking to aliens allowed.

      • Re: (Score:2)

        by nomadic ( 141991 )

        There are decades of studies showing therapeutic uses for psychedelics. There is no legitimate excuse for keeping say LSD as a schedule 1 drug.

        • Yeah, that's my point. The government determined they were safe, fun, and good for mental health, so they had to clamp down on that shit.

  • A very good animated series was made about this topic. https://www.imdb.com/title/tt2... [imdb.com]

  • Was kepts off the market for a total of 18 Deaths during trials that lasted years. 9 of those had pre existing heart conditions, and should have been exempted from the study... So 9 people over the course of YEARS. While one person approximately every 10 minutes, dies from Opiate OD in the USA. Make it make sense.

  • This is the problem (Score:2, Insightful)

    by drinkypoo ( 153816 )

    "There's a battle still raging in their mind that we don't fully understand biochemically," FDA Commissioner Marty Makary said.

    You never will understand it biochemically because it's not all biochemical, except in the sense that they are physical beings and we can describe the physical changes with chemistry. We cannot identify any biomarkers for most mental illnesses. We treat them chemically anyway, often with drugs with severe side effects. How many of the people whose symptoms we manage in this fashion (if they have to use the drug for the rest of their life, it's not a cure) are just reacting to their environment, which we del

    • NMDA receptor antagonists are safe, fun when used correctly, and pretty much the only psychoactive drug people should be bothering with. It's unfortunate that we have let Big Pharma do bullshit to it to finally get them in the Overton window, but we've known this for a long time.

  • "The voucher expedites the timeline only; it does not alter scientific or regulatory standards,"

    If you can expedite the process without lowering the scientific or regulatory standards, that should immediately raise the question of why your process was so slow in the first place.

    The quote carries the exact same meaning as: "Our normal timeline contains bureaucratic delays that do not improve scientific or safety outcomes".

    • Re: (Score:2)

      by PPH ( 736903 )

      without lowering the scientific or regulatory standards

      Wrong. TFS states: "it does not alter scientific or regulatory standards."

      I realize that all you stoners are waiting for the law to allow Dr. Feelgood to dash off prescriptions for all you "study participants". But let's just hold our horses until some real science is done on this stuff.

      • without lowering the scientific or regulatory standards

        Wrong. TFS states: "it does not alter scientific or regulatory standards."

        I realize that all you stoners are waiting for the law to allow Dr. Feelgood to dash off prescriptions for all you "study participants". But let's just hold our horses until some real science is done on this stuff.

        It appears you did not understand. This is very straightfoward Logic 101 propositional reasoning.
        "Lowering" something means to "alter" that thing in a downward way.
        Therefore, if you lower something, then you have altered it.
        Therefore, if something has been not-altered, then you definitively know that it has been not-lowered.
        So, if a Process can be done without altering Quality_X, then it necessarily follows that the Process can be done without lowering Quality_X.

        EXAMPLE:

        You are a frequent business traveler.

    • With them classed the way they have been it is very difficult to legally do much research at all, even while approving safety and efficacy would be the same as any other drug. Legally buying/transferring enough to legally give to volunteers who will need paperwork should they get drunk and screened by the police and set off a christmas tree of testing results all creates a lot of overhead. Upthread they were complaining it was synthetic for the study but it may be easier to legally produce the compounds sy

      • With them classed the way they have been it is very difficult to legally do much research at all, even while approving safety and efficacy would be the same as any other drug. Legally buying/transferring enough to legally give to volunteers who will need paperwork should they get drunk and screened by the police and set off a christmas tree of testing results all creates a lot of overhead.

        If that overhead can be reduced/expedited without altering the safety or regulatory standards, then why does that overhead exist in the first place?
        Who are the people who want lengthy overhead delays which are not part of maintaining safety/regulatory standards?

  • Hmmmm. (Score:3)

    by jd ( 1658 ) <imipak@ya[ ].com ['hoo' in gap]> on Wednesday April 29, 2026 @10:55AM (#66118326) Homepage Journal

    I don't criticise the concept, but the concern is whether it has long-term adverse neurological effects, and a "quick study" doesn't sound like it'll tell us that.

    It's essential we have more ways of dealing with treatment-resistant depression. We just need to make sure that they're less harmful than the depression itself. You willl, of course, recall that each and every single bad decision by medical boards to approve a treatment has been because they wanted to rush through a "medical cure" that turned into a medical hell.

    I'm not stupid enough to say that mushrooms would cause long-term damage, but equally I'm not stupid enough to say that we should only look to see if it has short-term benefits.

    The correct approach would seem to be to make sure there aren't any immediate hazards and, if there aren't, then to continue the study to check for consequences of long-term use whilst authorising short-term prescription use, on the understanding that the prescription use permission will be extended outwards to whatever the data cansafely tolerate. In other words, don't deprive people of necessary treatment but equally don't claim greater confidence than the data supports.

    This tightrope has only got to be walked because nobody has been seriously studying depression for a very long time and now we've got a hunge backlog of cases that are refusing to shut up, making it hard to ignore. This research should have been done years ago, but politicians were far too ignorant and far too swayed by religious money. But that doesn't mean we should rush.

    I'm sure the scientists know how to keep a level head, but the CEOs and the politicians clearly can't and they're the ones who will be making the demands.

    • 1) "quickly authorized study" is not "quick study"

      2) generally speaking, this entire class of drugs does not have lingering effects unless you make a regular habit of taking too much and traumatizing yourself with it

  • Dextromethorphan is available over the counter, and at the dose that's supposedly for suppressing a cough, (which it is clinically proven it does not do) it is a very effective antidepressant with practically no side effects after the first couple weeks. Because it's so weak compared to other NMDA receptor antagonists, you can dial in a very precise macrodose for anything from "I just think music is great" to "time loops" to "talking to the god in your head" to "kissing the void." It lasts six hours and has

    • In Plano, Texas maybe 1992, a dinner group of us took a shortcut across a vacant lot. The ground was littered with numerous Robitussin bottles. In around the same era, I was in a drugstore in Eureka, California buying clip-on sunglasses, when I overheard the pharmacist say "Susie, I can't sell you any more cough syrup on credit, until your mom pays the bill.'
  • I am reminded of this George Carlin bit from the 70s:

    The US Army has announced that although it is true they performed mind-destroying drug tests on hundreds of soldiers in the 1960s, none of the victims have been promoted beyond the rank of lieutenant colonel.

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