FDA Recognizes Psilocybin As 'Breakthrough Therapy' for Depression

The designation could be a prelude to approving the forbidden psychedelic drug as a medicine.



The only reference to psilocybin on the Food and Drug Administration's website appears in the agency's Bad Bug Book: Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins, where the psychedelic compound is described as a "neurotoxin" found in mushrooms. But according to the FDA, psilocybin is also a "breakthrough therapy" for major depression.

That designation, which the company seeking approval of psilocybin as a medicine announced this week, means "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies." Based on that evidence, the FDA agrees to "expedite the development and review of such drug."

The FDA's dueling portrayals of psilocybin as a scary fungal neurotoxin and a promising treatment for depression are part of a broader story about forbidden drugs, including MDMA, marijuana, and LSD, whose benefits scientists are once again studying with government approval after decades of neglect. The rehabilitation of these substances, which may ultimately make them available as prescription drugs, is a far cry from the pharmacological freedom that libertarians favor. But it represents a welcome return to empiricism in an area of public policy long driven by irrational prejudice.

A preliminary 2016 study sponsored by COMPASS Pathways, a British life sciences company, found big improvements in a dozen subjects with "treatment-resistant major depression" who received psilocybin in a "supportive setting." After one week, their mean score on the Quick Inventory of Depressive Symptoms, which has a scale ranging from 0 to 27, had fallen from 19.2 to 7.4, a 61 percent drop. Most of that progress was still apparent at three months, when the mean score was 10, or 48 percent lower than the baseline. Last August the FDA approved COMPASS Pathways' plan for Phase 2 clinical trials, which will involve 216 subjects at 12 to 15 research sites in Europe and North America.

Psilocybin research involving patients with life-threatening illnesses has found even more dramatic psychological improvements. A randomized, double-blind study reported in 2016 found that cancer patients who received active doses of psilocybin experienced an average reduction of 78 percent in depression and 83 percent in anxiety, based on an evaluation six months after their sessions. A similar study reported at the same time found that psilocybin-assisted psychotherapy "produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress."

Like MDMA, which the FDA also has deemed a "breakthrough therapy" and may approve as a treatment for posttraumatic stress disorder as soon as 2021, psilocybin is a psychotherapeutic catalyst that is meant to be taken no more than a few times, as opposed to a mood-adjusting drug taken every day. The striking results of these studies suggest the former approach may hold more promise of substantial, long-term improvement.

"This is great news for patients," COMPASS Pathways Executive Chairman George Goldsmith said in the press release announcing the FDA's "breakthrough therapy" designation. "We are excited to be taking this work forward with our clinical trial on psilocybin therapy for treatment-resistant depression. The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible."

If the FDA does approve psilocybin as a medicine, the drug will have to be removed from Schedule I of the Controlled Substances Act, which is supposed to be reserved for drugs that have no accepted medical use. In a 2018 Neuropharmacology review, Johns Hopkins psychologist Matthew Johnson and three co-authors argue that psilocybin should be placed in Schedule IV, which is for medically useful drugs with a relatively low abuse potential. They conclude that "psilocybin appears to offer potential benefits to patients and little risk to public health."

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  1. I’m not familiar with all species containing psilocybin but that picture is NOT what you are looking for in the Southern US.


    1. You’re correct, thump it first. If the thump-zone turns purple (and it looks like the right one) congrats. You’re high now.

      1. You better do an actual spore print.

    2. I used to grow psilocybe cubensis and they didn’t look like that. Actually I’m not that familiar with stropharia. Interesting. Do you know what the differences are in say psilocybin concentrations or anything like that?

      1. Oh wait. It appears that it’s just a different name for the same thing.

    3. Do those grow on chicken poop, SIV?

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  2. So what’s FDA’s position on marijuana? Still evil, and will only get you hooked on fentanyl?

  3. “breakthrough therapy”

    not like we roll and shroom to NOT have fun and be happy. wtf FDA?

  4. It’s hard to stay depressed when you take hallucinogens since it really puts things into perspective. After all, the walls could always be melting into your brain while a cat scratches it’s way into your chest cavity.

  5. UGH! It’s a private company and I can’t buy the stock. Boo!

  6. The pictured is: Psilocybe semilanceata otherwise known as the Liberty Cap.

    1. Is it poisonous?

      1. Yes. The good kind of poison :).

        1. Water is poisonous if you gulp down 2 gallons. And it is no fun to wolf down a bowl full of these mushrooms. Most of the population of Austin is wearily familiar with the relatively harmless growths–and with the harm caused by deadly laws that spout out of superstition and pseudoscience. LP also stands for legalize Psilocybin, Peyote and Pot. That has been in the party platform since 1972, when we had three orders of magnitude fewer voters.

          1. Cubensis and Cyanacens grow in the Austin area not Semilanceata which grows in the the upper West Coast.
            I suppose it is a matter if perspective if wolfing down a bowl is “fun” or not. And they are relatively harmless being the safest (statistically) of all recreational inebriates.
            It would take the consumption of 11 lbs. of fresh Cubensis to have a 50% of causing a fatality. One who attempted to consume this quantity would lose the ability to put things in ones mouth after a pound or so.

            1. Is that really what it takes to have an actual toxic dose? Good to know I suppose! One can definitely eat enough to where you FEEL like you’re going to friggin’ die with a lot less than that… Not that I’d have personal experience with an experience like that or anything…

          2. No, water is not poison no matter how much you drink. It can, if you drink too much at one time, cause your kidneys to become unable to excrete the excess water, and the sodium content in your blood can then become dangerous.

            1. How is that not “poisonous”? Carbon monoxide prevents red blood cells from carrying oxygen because red blood cells have a greater affinity for CO than O2. In small doses your body will dispose of the CO-locked red blood cells over time (and, like it does with all other disposed-of red blood cells, turn your poop brown), but inhalation of enough CO will outrun your body’s ability to swap out its red blood cells naturally.

  7. Unfortunately, the deck is almost always stacked against innovation for alternative treatments when they have to go up against the regulatory-pharma-medical axis which is stuck back in the 1950s.

  8. But will the FDA let me vape it?

    Would be hilarious if vaping was found to be the most effective delivery mechanism.

  9. Sullum has again outed the Kleptocracy’s FDA for its doublethink: “hold simultaneously two opinions which cancelled out, knowing them to be contradictory and believing in both of them.” But to bureaucratic Petromyzonidae, libertarian spoiler votes–votes that could easily replace them with another gang of looters just as dishonest and committed to the initiation of force–are tiebreakers convincing enough to overcome self-deception and repeal bad laws. All of a sudden THEY shall know the truth, and the truth shall set YOU free. All it takes is the courage to cast an honest vote (and maybe chip in for election expenses). Folks in many countries have no such opportunity, and are counting on Americans to set an example.

  10. Johns Hopkins psychologist Matthew Johnson

    Why should I change? He’s the one who sucks!

  11. I think the MDMA trial for PTSD used the same approach. They took people refractory to other forms of treatment and gave them several doses spaced apart combined with psychotherapy.

    For a placebo they used a low dose so the person would feel some effect and randomly assigned the subjects to low or high dose.

    Hope it works.

    Just don’t try it while watching the Wizard of Oz and listening to the Dark Side of the Moon at the same time.

    1. Yeah, that’s kind what I was wondering.

      It sounds like they got them properly high, but only a couple times. Before I read the article I was almost thinking they were talking about an ongoing microdose or something. That approach might do a little somethin’ somethin’ too, who knows.

      Seems weird that a couple “gettin’ high” doses would do much for clinical depression for an extended period though… But we really don’t know a lot about the nuances of brain chemistry, so there might be a reason it all makes sense.

      1. I’m thinking it is kind of the opposite of a stressful event that causes PTSD.

        These events usually are seared in the mind because they are so drastically different than the rest of your life. The fear/stress is then sort of embedded into your psyche.

        By creating a new event that is different than your normal reality that is not stressful and offers happiness and coping mechanisms, those good things are embedded into your psyche.

        That’s my theory at least.

  12. I want to know the progress on using shrooms to treat OCD.

  13. This just in! Shrooms make you feel good according to the FDA.

    You don’t say?

  14. It works. I speak from experience.

  15. Thanks for the information. It is really helpful.

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