FDA rejection of MDMA-assisted therapy rattles advocates but doesn't spell end of psychedelics in medicine, experts say

The US Food and Drug Administration (FDA) has rejected the use of MDMA for treating post-traumatic stress disorder (PTSD), requesting an additional Phase 3 trial to further study the safety and efficacy of the treatment. The decision comes after positive data from two late-stage clinical trials that used MDMA in combination with talk therapy. Advocates for the treatment expressed disappointment, while experts stressed the importance of the scientific process and the need for further data. The denial means that MDMA remains a Schedule I drug, and drug trials involving controlled substances require extensive approval processes.