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U.S. - FDA Recognizes Psilocybin As 'Breakthrough Therapy' for Depression

S.J.B.

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FDA Recognizes Psilocybin As 'Breakthrough Therapy' for Depression
Jacob Sullum
Reason
October 25th, 2018

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.

Read the full story here.
 
Psilocybin Tx Designation by FDA

Hooray! Making some progress...

"Psilocybin Gets Breakthrough Tx Designation For Treatment-Resistant Depression"
Psilocybin, the active ingredient in "magic mushrooms", has been granted Breakthrough Therapy designation by the Food and Drug Administration (FDA) for treatment-resistant depression.
The designation was granted to COMPASS Pathways, a life sciences company investigating psilocybin in a Phase 2b trial involving 216 patients at multiple sites across Europe and North America. "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," said George Goldsmith, Executive Chairman of COMPASS Pathways.
Discussing the outcomes of a proof-of-concept study conducted at Imperial College of London, Dr Robin Carhart-Harris, Head of the Psychedelic Research Group said, "In our 2015 study, we provided psilocybin to 19 patients in a clinical setting, coupled with psychological support, and found promising signals of efficacy and safety as treatment for treatment-resistant depression. The Breakthrough Therapy designation is a strong endorsement for the potential of psilocybin therapy."
Currently, psilocybin, a serotonin receptor agonist, is classified as a Schedule I drug in the US as it has not been approved by the FDA for any therapeutic use. According to a recent study published in the journal Neuropharmacology, the potential harms associated with psilocybin seem low and manageable when administered in a medically supervised setting. Based on their findings, the study authors went on to suggest that the drug should be rescheduled to a Schedule IV agent once it clears Phase 3 trials."


https://www.empr.com/drugs-in-the-pipeline/psilocybin-magic-mushroom-treatment-resistant-depression-breakthrough-therapy/article/809429/
 
I have found remarkable short-term relief from depressed moods via psilocybin. The benefits of a single dose can last for weeks, months even...it's as if the drug burns out all the residual negativity that's been building up in your brain, leaving the user with a contented & uplifted mood that persists long after the "acute effects" of the drug have worn off.

I'm sure that the benefits would be even greater if the drug were administered by a trained therapist within a controlled environment. Psilocybin is a drug with tremendous potential IMO. Moving it out of its current Schedule 1 status would be a great step in the right direction
 
I've experienced the benefits of good psilocybin trips for months after the experience. It isn't a permanent solution but 2.5 grams every 3-4 months is a million times better than taking SSRI's for years only to have them barely help.
 
I've experienced the benefits of good psilocybin trips for months after the experience. It isn't a permanent solution but 2.5 grams every 3-4 months is a million times better than taking SSRI's for years only to have them barely help.
Qft. I look forward to the day I can have access to this medicine.
 
Unfortunately i only had a supply enough to last me a year but it worked fairly well for that year and i still carry some of the lessons it taught me.
 
Congratulations FDA, for figuring out something humans have known for about 20,000 years
 
I read the article but saw no mention of how soon this could happen. Are they saying psilocybin/psilocin might be legally prescribed soon and if so, how soon?

Cause I'm hoping soon lol...
 
I read the article but saw no mention of how soon this could happen. Are they saying psilocybin/psilocin might be legally prescribed soon and if so, how soon?

Cause I'm hoping soon lol...

The story in the first post suggests that MDMA could be prescribed as soon as 2021, and it was designated a breakthrough therapy a little over a year ago. So, maybe "as soon as" 2022 for psilocybin? Let's hope!
 
Believe it or not I don’t think those are all that great for depression. LSD, 2c-_ tend to be better
 
That would bee a fantastic breakthrough!, despite it being ancient knowledge, it's well known too just how slow on the uptake politicunts are.

But even in the context of actual, genuine inadvertent consumption of psilocybin mushrooms in an effective psychotropic dose surprising a would-be consumer of only wild fungi of food value as a delicacy, 'neurotoxin' is an awfully strong word to use, and IMO not in the least applicable. It might well panic someone, or make them vomit, possibly, if they really weren't expecting psilocybin mushrooms in with their plate of sulfur polypore, boletes, parasol, for some misadventurous ID related reason, or say, somebody found Weraroa, and without cutting them through, believed them to be tasty puffballs and fried them up.

But neurotoxin? no. Muscarine is a neurotoxin, although not to be concerned about in the levels found in Amanita muscaria, which actually contains only miniscule quantities. Lethal quantities are to be found in some Inocybe species though, although one of the more easily hospital-treatable mycotoxidromes, given it's responsive to atropine if required for bradycardia, etc.

Monomethylhydrazine-N-formylhydrazone (gyromitrin, a pro-drug form of toxic monomethylhydrazine, from false morels), that is a fucking neurotoxin, un-decarboxylated ibotenic acid, is, sure, or acromelic acid, bona fide card carrying nasty ass neurotoxin that causes LOOOONG lasting (years even) painful thermo-responsive allodynia via excitotoxic effects on ionotropic glutamate receptors, possibly kainate type, in the spinal cord, from Clitocybe acromelalga, and C.amnoelens. That sort of thing, is a fungal bloody neurotoxin, not psilocybin.

Even if it produces ill effects on someone, it isn't a poison, it's a bad response to the dynamic psychological effects of the substance, unpleasant to the subject. Or some GI squirrely guts due to the serotonin receptors present in the GI tract. But not a POISONING....

In terms of the good, the bad and the truly heinously virulent ugly motherfuckers of the mycological chemical world, psilocin/psilocybin is a veritable angel. You cannot compare a subjective panic response to a strange psychic effect, to actual, physical neurological damage, or things like cyclopeptide toxins which rip the liver to shreds, allenic norleucine that rapidly attacks the kidneys (Amanita smithiana fr.ex), the paraquat-esque bipyridyls from deadly Cortinarius webcaps that cause severe, very delayed kidney failure, or the rhabdomyolytic toxins from certain Russula (R.subnigricans) and Tricholoma flavovirens if eaten to excess in the latter case (formerly considered good eating, but T.flavovirens, syn. T.equestre, the man on horseback, or knight's shield, actually contains toxins that if multiple meals are eaten, and too much mushroom is consumed over a few days can result in severe rhabdomyolysis, and the Russula subnigricans, that is actually lethal, ripping apart muscle tissue from the inside, flooding the body with it's breakdown products that then shuts down the kidneys, in addition to directly attacking and damaging cardiac muscle tissue.

Psilocybin fungi aren't even in the running. No way, no how. Not unless you actually choke as you swallow them, is anyone going to die, save perhaps a little baby grazing and finding something like P.baeocystis, which I do recall, a long time ago, reading that a fatality occured. Still, one newborn infant, as a misadventure of the most tragic kind, does not a neurotoxin, or even a true poison make, IMO.

Some people are made sick even by things the rest of us eat. Honey fungi are an offender there, sulfur polypore sickens some who eat it, but I eat both, and I love sulfur polypore fritters in eggy bread batter, deep-fried. Yum.
 
Perhaps I ought to apologize slightly, maybe I did go off on one there, as a lifelong avid mycophage who'll eat anything that isn't toxic at least once, as long as it isn't the equivalent of a block of wood, like a dried out bracket fungus, or something horrible like an adult stinkhorn. Did get made sick as a kid after stinkhorn egg stages once, puked up all night.

But hm...I do rather like my wild fungi, I've a soft spot for the science behind even the amatoxins and tricothecenes. Not to say I'd eat something containing either, I sure as hell wouldn't, but I've rather a soft spot for fungal life, have had ever since I was 4yo and started reading, from a mycology textbook=D

So mea culpa, but still...neurotoxin?
 
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