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FDA advisors voted against MDMA therapy – researchers are still fighting for it (www.bbc.com)

submitted 5 months ago by [email protected] to c/[email protected]

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Some 13 million Americans struggle with post-traumatic stress disorder (PTSD). Existing therapies only bring relief for a fraction of patients, and new treatments are sorely needed, according to psychiatrists wrestling with the scale of the problem. So, there was distinct disappointment when an advisory committee at the US Food and Drug Administration (FDA) voted earlier this month against a therapy that many had hoped could offer the first new treatment for PTSD in 25 years.

A number of experts who study psychedelics have since spoken out in support of MDMA-assisted therapy for PTSD and have sharply criticised the recommendations of the FDA's Psychopharmacological Drugs Advisory Committee. But some are still optimistic that the treatment might be approved when the FDA delivers its final decision in August.

Ahead of the meeting, FDA approval of MDMA-assisted therapy for PTSD seemed likely, says Sandeep Nayak, an assistant professor of psychiatry at Johns Hopkins University, who investigates psychedelics as treatments for substance use and mood disorders. About two-thirds of people who received three sessions of MDMA and talk therapy no longer qualified for a PTSD diagnosis at the end of two Phase 3 clinical trials.

It's an outcome that is "almost double that of existing medications", says Gül Dölen, a neuroscientist at the University of California, Berkeley, who researches the mechanisms of how psychedelics achieve therapeutic effects. "What's more, [the treatment] led to durable improvements in these patients lasting at least six months."

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[–] [email protected] -4 points 5 months ago (24 children)

Nobody argued everyone's the same.

All of the arguments that are put forth for using MDMA to treat PTSD symptoms already work for over 80% of patients using a single treatment of psilocybin that is already available.

Go ahead and research MDMA, but don't deny people an available, effective, safe and simple treatment while we wait for the development of experimental therapies.

[–] [email protected] 6 points 4 months ago (23 children)

Again you're spouting statistics with no scientific evidence to support them. I remember that study you linked with the 80%. That rate was not for PTSD but other chronic mental health conditions being treated with psilocybin.

Your claims have no evidence to support them so please stop. Because you're not helping.

[+] [email protected] -7 points 4 months ago (22 children)

It's fine if you didn't read or don't like that study.

Those symptoms resolved by psilocybin are the same as the PTSD symptoms that MDMA hopes to treat one day.

You not liking a particular medication doesn't make it less effective or safe for people.

You might want to check out the news recently though,, MDMA is specifically not being approved last weekend this week because a safe therapy has not been found, unlike with psilocybin.

Psilocybin is safe, simple and effective.

Controlled studies have born this out.

[–] [email protected] 7 points 4 months ago (1 children)

You do know the hope is not to treat symptoms but underlying disorders, right?

[–] [email protected] -4 points 4 months ago

That's close.

Ptsd is much more effectively treated when you deal with the symptoms and the disorder itself instead of just focusing on The disorder and ignoring the symptoms.

Luckily, psilocybin therapies work on both symptoms and disorders.

I mentioned symptoms specifically because MDMA therapies are specifically focused on the symptoms right now that psilocybin already effectively treats.

So you can take the effective and perfectly safe psilocybin therapy regimen to alleviate symptoms and the disorder itself while focusing on supplementing that treatment with more traditional therapies to dig deeper into the disorder.

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