FDA denies MDMA, ecstasy-based drug, to treat PTSD
FDA denies MDMA, ecstasy-based drug, to treat PTSD
The FDA said there wasn't enough data showing the drugs helped patients and asked for another clinical trial.
The US has denied a bid to allow MDMA, commonly known as ecstasy or molly, to be used in the treatment for post-traumatic stress disorder (PTSD).
The US Food and Drug Administration (FDA) was examining the psychedelic drug made by Lykos Therapeutics to treat the mental health disorder in combination with talk therapy.
The FDA approved OxyContin when OxyContin was heroin, so FDA doesn’t mean jack shit.
Okay I'll just go back to killing myself with alcohol so I can sleep
I’m a few weeks into sobriety and I gotta say, stopping drinking is an amazing feeling. I only had trouble sleeping one or two nights.
It's best to kill your self with governmental approved drugs.
When they deny something like this because of claimed flaws in study, do they give detailed descriptions of the flaws and help (maybe for a fee) the petitioner make a new study?
Or do they leave it vague enough so they can just perpetually say it's flawed?
Personally, I want FDA approval to mean it is as provably safe and effective as possible. They said they wanted more evidence before approval, and I think that’s okay. Good, even.
The way the US treats recreational drug use and self-medication is horrific, but it’s not really the domain of the FDA.
I would rather have not-yet-FDA-approved legal-for-personal-use mdma than what we have now or an unproven drug approved by the FDA.
IIRC, advocates in this space were expecting this outcome. The research around MDMA-based treatment is promising but not quite there yet.
Psilocybin-based treatment, on the other hand, is looking more solid.
Ketamine as well.
Shouldn't it need to be shown to be unsafe to remove people's choice to use it though? Proving it safe would be great, but the claim to prevent usage should be that it's harmful. It's removing a choice. We shouldn't have to prove everything is safe to be allowed to do it. We do plenty of things that are unsafe, but these drugs aren't allowed for no good reason.
Allowing anyone to just sell whatever chemical they come up with without first showing that it's safe would be insanely irresponsible.
But police can inject you with ketamine if think think you are too much lol
That's fucked. Multiple studies have literally proven even a single MDMA session can CURE treatment resistant PTSD 2 times better then placebo. Oh... I see. Perhaps they don't want someone to take something once or just a couple of times and be cured. Call me crazy but I think they want you to keep taking something for life that won't cure you, but just help you manage it. Better for business.
Exactly. Why have a cheap, one off drug when you can make billions with something expensive that'll be needed for the duration of your life, and might possibly give you side effects that'll require additional drugs that they also happen to sell? To not do so would be socialism!
Just give ‘em some high fructose corn syrup or aspartame amirite?
booooooooooooooo
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