FDA reviews MDMA therapy for PTSD, citing health risks and study flaws
The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company's studies that could pose major hurdles to approval of a treatment expected to help people who struggle with the condition.The agency said bias crept into the studies because participants and therapists were easily able to tell who received MDMA versus a placebo. It also reported “significant increases” in blood pressure and heart rate that could “trigger cardiovascular events.”The staff analysis was conducted for an independent advisory panel that will meet Tuesday to consider an application from Lykos Therapeutics to use MDMA-assisted therapy. The agency's concerns highlight the unique and complex issues facing ...