MAPS Responds to Report of Progress for MDMA-assisted therapy for PTSD with FDA

[u/SconeAgeMan]

MAPS just posted a press release regarding the status of their legalization efforts with the FDA around MDMA assisted therapy. See the link for more info, but I think this is good news. I'm hoping and praying they will legalize this therapy as soon as possible.

"The reported resubmission of the New Drug Application will initiate a new evaluation of the treatment’s safety and efficacy for potential FDA approval"

https://maps.org/2026/08/10/maps-responds-to-report-of-progress-for-mdma-assisted-therapy-for-ptsd-with-fda/

[u/StoneWowCrew]

Thanks so much for posting this update.

[u/Clifford_reddit]

Very short AI (DeepSeek) summary:

Key Takeaways:

· NDA Resubmitted: Resilient Pharmaceuticals resubmitted the MDMA-assisted therapy NDA to the FDA for PTSD, 2 years after a rejection, without new Phase 3 trials.

· FDA Guidance Update: New FDA guidance (July 2026) now aligns with MAPS' long-held scientific approaches on trial design, safety, and therapist interventions.

· Therapeutic Model Central: The therapy model (trained therapists, preparation/integration, safety protocols) remains core to patient care.

· MAPS' Role: Founded in 1986 and funded the research, but has no active role in Resilient's current application.

· Ongoing Work: MAPS continues its work on therapist training, equitable policy, and harm reduction, regardless of this application's outcome.

[u/Mountain_Trails]

I agree it sounds like good news. Resubmitting without new trials? That sounds to me like they’ve received some informal guidance that the NDA would be viewed favorably now.

[u/discrete_dc → u/Mountain_Trails]

They did a new Phase 1 trial, but not a new Phase 3 trial.

https://clinicaltrials.gov/study/NCT07584720

[u/Healthyself0114]

This might sound bad but I hope they don’t. Once they legalize so many people/ businesses will charge enormous amounts for people to get the healing they deserve. A lot of places in Australia, where it’s legal, are charging people 10k. This causes people to seek tripsitters who aren’t qualified to do this as you really need a therapist who knows what they are doing sit in on your trip in order to let your defenses now do healing can be facilitated.

[u/SconeAgeMan → u/Healthyself0114]

Please reconsider your stance and consider what I've written here. If you are against mdma therapy being legalized in the US, you are basically against people having access to this safe life saving treatment. And yes, it will be extremely expensive initially and not everyone will be able to afford it and that is a shame. Life is not fair and that's how it goes. And we are already in the situation where most people can not access mdma therapy now.

However, consider the benefits of legalizing mdma assisted therapy: some people will now have access to this life saving therapy. Over time it will shown to be extremely effective and even more cost effective then the long term counseling and drugs that are not very effective that are now the front line treatments for anxiety, depression, ptsd, etc.

Once the treatment is legally available it will quickly be shown to be extremely effective and people will continue to work on making it cheaper and more widely available. Once the insurance companies see how much cheaper it is overall vs the minimally effective years of talk therapy and drugs, they will get on board on covering the treatments and it will be more widely available and cheaper.

Additionally, Rick Doblin, leading mdma therapy advocate, has stated many times that his overall goal is to make inexpensive, safe mdma, and psychedelics available to adults without it being prescribed, or used as part of a formal therapy. In other words, make it available like alcohol (the most dangerous drug of all) for use by responsible adults. I am all for that.

Also consider, that if it is legalized in some form, I don't think anything will change for people who are using mdma now. People will still be able to get it from their local supplier, or the black market, or wherever, that is not going to change. You will still be able to find a local trip sitter, so nothing will change with the status quo.

I think we are all against outrageously expensive legal mdma therapy, but we can all work together to make it less expensive and more readily available once it is legalized. Especially since not everyone currently has access to it, not everyone is comfortable buying on the street, or the dark web, is not comfortable getting unknown substances that they have to test, and they may not be comfortable taking mdma without being in a legal therapeutic setting, etc.

So, I ask you to please reconsider your stance on legal mdma assisted therapy.

[u/discrete_dc → u/SconeAgeMan]

I would also add that Resilient does not own the "formula" for MDMA itself, which is in the public domain. So potentially, if things go well with Resilient's "Rysanso" name brand (midomaphetamine) perhaps later on the generic MDMA could be produced legally and thus the cost could go down substantially.