FDA's rationale for rejecting medicinal MDMA

cleft

cleft

Bluelighter
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Oct 25, 2025
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Can someone provide details on the FDA panel members' explanation for rejecting MDMA therapy?

Another potential sticking point was the lack of data about how patients experienced the acute effects of the drug, including feelings like "euphoria" or "elevated mood." That data helps inform the FDA's assessments of the drug's abuse potential.
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Above is the quote from NPR. What exactly is the problem? Does it mean that the policy prohibits any drug that's above some euphoria score?
 
I'm no expert, but the quote cites a lack of data. They seem to be saying is: "We know this drug can get people high. But we don't know how high, or what it means for the addiction potential."

In general, health agencies like to be sure about stuff like that before drugs are approved. Also note that even very addictive drugs can be prescribed and used medically, it's just that their use-cases are strictly limited. Reserved for hospice patients, surgical operations or a last resort when all other treatments fail.

And decisions to approve or reject something can be revised. It happens a lot. So I wouldn't say that this means it'll never be approved. Just that (in the US) it's probably not happening any time soon.
 
cleft said:
Addiction potential is irrelevant for moving something from Schedule I to Schedule II, because Schedule II substances are classified as having a high potential for abuse. The only way forward in the US is state referendums, which seem unlikely, since MDMA is much less popular compared to cannabis.
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Interesting to know.
 
Schedule 1 is suppose to be "No medicinal use" -- Which if you look at the list will see is a joke pretty quickly starting with marijuana. None? one of the oldest --- w/e

Heroin -- No medical use? Really not even in a pinch? (Or is H sched 2?)
 
and we all know Diacetylmorphine is utterly useless for pain ...... Fentanyl on the other hand lol

I don't know if I can think of ANY drug that is completely useless medicinally -- youse guys? (Mental health counts too)
 
If you read what happened during the MDMA trial, and in particular listen to the podcast POWER TRIP.

There was a significant failure of MAPS acting on very poor run studies, including the development of patient/doctor relationship which was against MAPS policy.

MAPS failed to act decisively and appropriately to the situation.

So it’s back to the drawing board for a few years as the process gets refined.

It’s difficult to manage therapy when the drug facilitates social/personal connection.
 
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