
FDA agrees to expanded access program for MDMA-assisted psychotherapy for PTSD - OrgNet
https://www.healtheuropa.eu/mdma-assisted-psychotherapy-for-ptsd-approved-by-fda/96931/
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skunkworker
Title is a little unclear, this is for an "Expanded Access Program", for
individuals who are unable to participate in a clinical stage 3 trial. [1]

"Sometimes called “compassionate use”, expanded access is a potential pathway
for a patient with an immediately life-threatening condition or serious
disease or condition to gain access to an investigational medical product
(drug, biologic, or medical device) for treatment outside of clinical trials
when no comparable or satisfactory alternative therapy options are available.
"

[1] [https://www.fda.gov/news-events/public-health-
focus/expanded...](https://www.fda.gov/news-events/public-health-
focus/expanded-access)

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pmoriarty
Here is what MAPS (the organization running the Phase 3 trials of MDMA-
assisted psychotherapy and the same organization that applied for expanded
access) has to say about this: [1]

Donate to MAPS, people, if you believe in this!

[1] - [https://maps.org/news/media/8008-press-release-fda-agrees-
to...](https://maps.org/news/media/8008-press-release-fda-agrees-to-expanded-
access-program-for-mdma-assisted-psychotherapy-for-ptsd)

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jokowueu
Click bait title

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TurkishPoptart
Agreed, how about we change it to: "FDA Agrees to Expanded Access Program for
MDMA-Assisted Psychotherapy for PTSD"

~~~
dang
Ok, we'll use that. Thanks!

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linuxftw
There's an entire industry of psyche meds already. And they all have 'trials'
proving their efficacy. Do those pills not work? Is it all a sham?

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rincebrain
Many psychiatric medications exist, but since most of the things we group
together as depression or generalized anxiety or others are some subset of a
large number of possible causes, efficacy of these pills for any given person
is rolling the dice, and takes O(months) to test a given med (for depression
and bipolar meds, at least - O(weeks) per dose change).

Plenty of people can testify to the efficacy of some of these meds for them
personally, but even within families, having an immediate family member who
responded well to a given drug is no guarantee it'll work well on you (though
it's still better odds than without that data).

Also, drugs+therapy leads to a better outcome, generally, than just drugs. So
having more tools available, particularly a tool that improves the efficacy of
therapy, is definitely a win.

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phkahler
This is different than other medications. You dont prescribe it. It's only
used during therapy sessions. Long term use IIRC causes brain lesions or
something like that.

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sibeliuss
> Long term use IIRC causes brain lesions or something like that.

This is actually FUD based on an experimental mishap:
[https://en.wikipedia.org/wiki/Retracted_article_on_dopaminer...](https://en.wikipedia.org/wiki/Retracted_article_on_dopaminergic_neurotoxicity_of_MDMA)

