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 obstacles to approval of a treatment anticipated to help people struggling with the condition. The agency said that bias had seeped into the studies because participants and therapists were readily able to figure out who got MDMA versus a placebo. It also flagged “significant increases” in blood pressure and pulse rates that could “trigger cardiovascular events.”The staff analysis was conducted for an independent advisory panel that will meet Tuesday to consider an application by Lykos Therapeutics for the use of MDMA-assisted therapy. The agency’s concerns highlight the unique and complex issues facing regulators as they weigh the therapeutic value of an illegal drug commonly known as Ecstasy that has long been associated with all-night raves and cuddle puddles. Approval would mark a seismic change in the nation’s tortuous relationship with psychedelic compounds, most of which the Drug Enforcement Administration classifies as illegal substances that have “no currently accepted medical use and a high potential for abuse.”

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Persons: ” Organizations: Drug Administration, Lykos Therapeutics, Drug