The safety and efficacy data on the use of MDMA for PTSD therapy is 'challenging to interpret,' with significant flaws in trial designs and cardiovascular safety concerns, according to the FDA briefing document.
If the FDA approves MDMA for PTSD treatment, it would signify a significant change in the government's stance on psychedelics. However, the FDA will review evidence and vote on efficacy and risk assessment before making a decision.
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