Federal health regulators declined to approve MDMA for PTSD therapy, highlighting data limitations. FDA requested a late-stage study, potentially delaying the drug's approval for several years and millions in costs.
The FDA's decision to not approve MDMA for PTSD therapy follows expert scrutiny on risks like heart problems, injury, and abuse. If approved, MDMA would have been the first illegal psychedelic as a federally approved medicine.
FDA stated that the MDMA application had significant limitations, preventing a conclusion on its safety and effectiveness for PTSD. The agency remains open to innovation for psychedelic treatments and other medical needs.
Collection
[
|
...
]