FDA agrees to expanded access program for MDMA-assisted psychotherapy for PTSD

https://www.healtheuropa.eu/mdma-assisted-psychotherapy-for-ptsd-approved-by-fda/96931/

by OrgNet • 6 years ago

142 14 6 years ago

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...

jokowueu• 6 years ago

Click bait title

TurkishPoptart• 6 years ago

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

dang• 6 years ago

Ok, we'll use that. Thanks!

pmoriarty• 6 years ago

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...

linuxftw• 6 years ago

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?

xerox13ster• 6 years ago

There's plenty of psychotropic medications, but none specifically for PTSD or CPTSD (most likely to be treatment resistant), of which I'm aware. I asked my psychiatrist and many of my friends have asked theirs and it's all similar answers. The only real medication for flashbacks is prazosin, a med that was originally a blood pressure medication that they found to be effective in blocking nightmares of a traumatic origin.

jr46tjdr• 6 years ago

Surprisingly, treating these kinds of conditions is difficult and many pills are not yet archetypes of a cure.

cc81• 6 years ago

MDMA has a very measurable effect but what is interesting if it can be combined with therapy. I saw a short youtube-video about one of those trials and the that patient they interviewed seemed positive (yes, I know n=1) because MDMA at that dosage was like she was just her best self and had the best day which made talking about her difficult experience with the therapist so much easier.

Time will tell if it works long term and that those types of therapy sessions are positive but considering the type of drug (you only take it during therapy) and the dosages it seems pretty harmless.

rincebrain• 6 years ago

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.

phkahler• 6 years ago

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.

sibeliuss2• 6 years ago

It works profoundly well. As documented in the experimental trials, chronic PTSD, in a majority of cases, was cured after three sessions + therapy.

sprafa• 6 years ago

Having taken both a lot of psych meds are worst for you and have far more side effects than many illegal drugs.

A famous talk from a psychiatrist talked about antidepressants vs alcohol and how in virtually every measure, healthy consumption of alcohol is an excellent antidepressant with fewer side effects than many medications.

FDA agrees to expanded access program for MDMA-assisted psychotherapy for PTSD

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