The FDA noted bias in the studies because participants and therapists could easily tell who received MDMA versus a placebo
The Food and Drug Administration (FDA) expressed concerns about using MDMA (commonly known as Ecstasy) to treat post-traumatic stress disorder (PTSD), citing flaws in studies conducted by Lykos Therapeutics.
The FDA noted bias in the studies because participants and therapists could easily tell who received MDMA versus a placebo. It also flagged increases in blood pressure and pulse rates that could lead to cardiovascular issues.
These concerns may pose major obstacles to the approval of MDMA-assisted therapy, anticipated to aid individuals struggling with PTSD.
Despite these challenges, research on MDMA therapy for PTSD has garnered support from various groups and lawmakers, especially due to its potential benefits for military veterans.