Breakthrough status for psilocybin for treatment of depression

[Mezcalito]

Psilocybin is more and more following the footsteps of Ketamine for treatment of mental disorders (even the same indication)?

Breakthrough designation by FDA doesn't mean that it's already generally accepted therapy, but it opens one of the most common psychedelic substances furthermore to serious research and would potentially lead to a rescheduling (currently schedule I, for a substance that's not addictive or causes bodily harm?!?) .

"The research is investigating the optimal dose range for psilocybin in regards to severe treatment-resistant depression."
Phase IIb clinical studies is a quite advanced stage, Rick Strassmann's DMT research in comparison was for sure not more than Phase I.


here's a link, I hope it's ok:

Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA

In an extraordinary step forward for the psychedelic drug research community, the US Food and Drug Administration (FDA) has just given psilocybin therapy for treatment-resistant depression a Breakthrough Therapy designation. This classification suggests the treatment has demonstrated significant…

newatlas.com

 

[Loveall]

Thanks for posting the news.

I hope this all goes well. It seems that COMPASS is behind this, which could be a concern for future access and price for the paitients that could benefit from wat should simply be a free gift of nature.

I hope it all works for the best in the end.

 

[benzyme]

Afaik, this has been updated to Phase III, with possible C-IV scheduling, which is huge. That means by legal definition, it has lower potential for abuse than most anti-anxiety meds, and ketamine (C-III).

 

[Jees]

Psilocybin is more and more following the footsteps of Ketamine for treatment of mental disorders (even the same indication)?

Breakthrough designation by FDA doesn't mean that it's already generally accepted therapy, but it opens one of the most common psychedelic substances furthermore to serious research and would potentially lead to a rescheduling (currently schedule I, for a substance that's not addictive or causes bodily harm?!?) .

"The research is investigating the optimal dose range for psilocybin in regards to severe treatment-resistant depression."
Phase IIb clinical studies is a quite advanced stage, Rick Strassmann's DMT research in comparison was for sure not more than Phase I.


here's a link, I hope it's ok:

Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA

In an extraordinary step forward for the psychedelic drug research community, the US Food and Drug Administration (FDA) has just given psilocybin therapy for treatment-resistant depression a Breakthrough Therapy designation. This classification suggests the treatment has demonstrated significant…

newatlas.com

Hi Mezcalito, there is a lot of stir around this:
COMPASS, MAPS, Open Science, and For-Profit Approach to Sanctioned Psychedelics
When big money shoves in, states and laws crumble humble. An effective way to crack those laws is by the shear power of brute money?

 

[boots]

There is one thing boots hopes to see when the laws change regarding shrooms, which is that their sales be regulated in the regard of consumer education. As an example, legalize it in such a way that to get a purchase license you must first take and pass a course about best practice & harm reduction.

Part of what boots thinks keeps the harm out of the equation with shrooms is precisely because they are an illegal substance. The average person does not get into them much, while those who seek the experience will tend to educate themselves about it so that they don't do anything stupid and wind up in serious trouble. Like, imagine the headline, "man on shrooms drives into family of 3 killing all involved."

These plants already have a tough time being socially accepted, laws aren't going to change that unless the level of understanding is brought up.

Boots hates to put it this way, but: we live in an age where unsuspecting people consume Tide Pods.

 

[POST BALONE]

glass half full here .

it is either going to take a full stop reset or loads and loads of time before these elements recover from how hard they were stigmatised by "them"

either way i doubt we see it in our lifetime .

for some reason there has been this push on cannabis that we see but it is still super stigmatized. they really did a number on psychedelics by weaponizing them , and then the whole "dose and toss" ( out the fifth story window of a hotel ) turned into a meme that still thrives .

it makes me happy thinking about all this evil and pleases me to no end that we are perceived as being "free" .

wait , reverse that .

 

[Jees]

There is one thing boots hopes to see when the laws change regarding shrooms, which is that their sales be regulated in the regard of consumer education. As an example, legalize it in such a way that to get a purchase license you must first take and pass a course about best practice & harm reduction....

My idea exactly :thumb_up: