FDA Approves First Psilocin Clinical Trial (greenmarketreport.com) 36
An anonymous reader quotes a report from Green Market Report: Exclusively-natural psychedelic drug discovery company Filament Health Corp. received authorization from the FDA authorization to initiate the first clinical trial using naturally-sourced psychedelic substances. The news caused the stock to jump over 11% in early trading. The company said that this approval is the first for the direct administration of psilocin rather than its prodrug psilocybin and will administer Filament's three proprietary botanical drug candidates. The phase 1 trial is led by the Translational Psychedelic Research Program (TrPR) at the University of California San Francisco (UCSF).
The phase 1 trial has been designed to include 20 healthy subjects and will examine the effects of Filament's three proprietary botanical drug candidates: PEX010 (oral psilocybin), PEX020 (oral psilocin), and PEX030 (sublingual psilocin). As a result of the need for psilocybin to convert into psilocin before becoming active in the human body, the direct administration of psilocin may yield several therapeutic benefits such as faster onset time, greater consistency, increased bioavailability, and lessened side effects. These potential attributes are being studied in the authorized trial. In addition, psilocin is an ideal candidate for sublingual delivery because of the bypassing of the gut, where the conversion to psilocybin is thought to primarily occur. To date, synthetic manufacturers have been unable to produce a stable formulation of psilocin and enter it into a clinical trial. "We are excited to announce this milestone as validation of our ability to cultivate variable psychedelic biomass and transform it into pharmaceutical-grade drug candidates," said Chief Executive Officer, Benjamin Lightburn. "Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin, and to enter them into an FDA-approved natural psychedelic clinical trial. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation."
The phase 1 trial has been designed to include 20 healthy subjects and will examine the effects of Filament's three proprietary botanical drug candidates: PEX010 (oral psilocybin), PEX020 (oral psilocin), and PEX030 (sublingual psilocin). As a result of the need for psilocybin to convert into psilocin before becoming active in the human body, the direct administration of psilocin may yield several therapeutic benefits such as faster onset time, greater consistency, increased bioavailability, and lessened side effects. These potential attributes are being studied in the authorized trial. In addition, psilocin is an ideal candidate for sublingual delivery because of the bypassing of the gut, where the conversion to psilocybin is thought to primarily occur. To date, synthetic manufacturers have been unable to produce a stable formulation of psilocin and enter it into a clinical trial. "We are excited to announce this milestone as validation of our ability to cultivate variable psychedelic biomass and transform it into pharmaceutical-grade drug candidates," said Chief Executive Officer, Benjamin Lightburn. "Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin, and to enter them into an FDA-approved natural psychedelic clinical trial. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation."
Serotonin adjusments-- (Score:2)
Interesting.
LSD, and the psychedelic drugs family in general, were the first of the class of serotonin-adjustment drugs; decades before Prozac. I've always wondered why Prozac etc. got used for treating serotonin-deficiency syndromes, and the psychedelics were ignored.
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Follow the money?
Re:Serotonin adjusments-- (Score:4, Funny)
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It's more that drugs like Prozac can be patented while it's kinda hard to do the same with a stuff that grows in a plant.
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Cue the wisecracker with the unrelated nugget of wisdom that neither anyone asked for nor adds to the discussion.
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Interesting.
LSD, and the psychedelic drugs family in general, were the first of the class of serotonin-adjustment drugs; decades before Prozac. I've always wondered why Prozac etc. got used for treating serotonin-deficiency syndromes, and the psychedelics were ignored.
It's right in the summary: "Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation". Same reason.
Re: Serotonin adjusments-- (Score:2)
LSD and other psychedelics weren't used because they were strictly and very forcefully forbidden in the US due to the recreational drug usage scare of the 1970's. For decades it was practically impossible to get anything clinical with them, including mere scientific trials, approved. It took the typical two generations, with most of the then frightened population, old enough and out of politics enough, plus a new generation very critical of theirs, for these social barriers to start crumbling.
This generatio
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Policy makers also had some very convenient hooks like the Manson Family who was known for LSD usage. And anyone who disagreed could easily be dismissed.
It's very closely related to the Four Horsemen of the Infocalypse [wikipedia.org]. The general principle of these "killer arguments" goes beyond just the internet as a platform. Something to keep a close eye on in these times.
But since there's also a lot of potential money in there, synthetic variants tha
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I've always wondered why Prozac etc. got used for treating serotonin-deficiency syndromes, and the psychedelics were ignored.
Because any asshole with a cooler and a jar of rice can make his own psychedelics, but you have to pay for prozac et al. Plus, psychedelics can actually cure some emotional problems, while commercial pharmaceuticals are only for managing them. Follow the money, that's the primary benefit of capitalism.
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Follow the money, that's the primary benefit of capitalism.
Follow it to OneCoin and WeWork you stupid capitalist wanker.
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Make sense or fuck right off, kthxbye noob
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Plus, psychedelics can actually cure some emotional problems, while commercial pharmaceuticals are only for managing them.
Can you give any more information about this? I've read very little, like a case study of a girl that was cured of bipolar by accidentally taking 11 doses of LSD. (She intended to take a little more than one dose.) But other people with bipolar take hallucinogens, and the more common result is that it may possibly cause an episode. One could speculate that the girl might have had other issues that were misdiagnosed as bipolar.
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All the studies so far have been very small, but there is some evidence that the positive effects of psychedelic experiences can be long-lasting. Here [nih.gov] is an example where there was a follow-up after 12 months (from a single dose). From the results: "On the PEQ, positive attitudes about life and/or self, positive mood changes, altruistic/positive social effects, positive behavioral changes, and well-being/life satisfaction significantly increased at 1 and 12 months and were subjectively attributed by the sub
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Apparently, you can't just take psychedelics & be magically cured.
I know more than a few people who have done quite a bit of psychedelics and some of them clearly benefited from the experiences, and some clearly didn't and in fact some obviously could have done better without. But I think it's incorrect to say that you can't just take psychedelics and be cured, though I'd argue there's nothing magical about it. In a lot of cases we know the answers to our questions but are afraid to admit them, and psychedelics seem to reduce one's ability to inhibit thoughts.
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Why medicine abandoned psychedelics (Score:2)
There's some history in the book "Changing Your Mind", which is about psychedelics and what they can do. There is an alternate history in which they might have been developed as mainstream psychiatric treatments.
There's a lot of detail, but it can be summarized as people saying that it's too simple to blame Timothy Leary for discrediting the entire field, but he's to blame for discrediting the entire field.
Nerding out, the last I heard (years ago) there were open questions about the model of depression as a
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The feds were dosing all kinds of people knowingly and unknowingly early on. See https://en.wikipedia.org/wiki/... [wikipedia.org]
Re: Serotonin adjusments-- (Score:1)
I heard tales of the British Army doing the same, from one of the test subjects. They presumably needed to understand the threat to their ability to coerce others, if for example someone dosed their tame killers.
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Interesting.
LSD, and the psychedelic drugs family in general, were the first of the class of serotonin-adjustment drugs; decades before Prozac. I've always wondered why Prozac etc. got used for treating serotonin-deficiency syndromes, and the psychedelics were ignored.
One of them is basically free and has a reputation for inducing visions of rainbows and unicorns, or occasionally something even darker and more frightening. The other is said to induce calmness or mild euphoria. If you were a tight-assed official with an iron-clad grip on a specific view of reality, which would you legalize and which would you demonize?
Add in that one is hugely profitable and the other is essentially free, and there's your answer. In the current case they've found a way to monetize the 'ba
Here's a good video on the subject (Score:3)
I Wonder (Score:1)
if Joe Rogan will apply for the clinical trials?
Re:I Wonder (Score:4, Informative)
No need. Rogan has already tested EVERYTHING himself.
Which is why he thinks goat paste designed to go after parasites will have any effect on a virus.
FDA Approves First Psilocin Clinical Trial (Score:2)
WTF? Are they tripping?
The irony (Score:2)
www.history.com/topics/crime/history-of-lsd
Funny how something that was originally intended to be a weapon used by "The Man" turned into a thing of rebellion.
It won't be the first irony, seeing how Hitler's "People's Car" (Volkswagen) became popular amongst this set.
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Re: The irony (Score:2)
The US government wanted to 'weaponize' it in the 1950s. And it was shortly after this that LSD became popular amongst the counterculture crowd.
How could the Curies and others in the budding field of radiation research predict that the peculiar and wonderous curiosity would end up becoming a weapon of mass destruction feared all over the world only decades later?
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