FDA’s review of MDMA cites 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 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 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.”

Research like the current studies on MDMA therapy have corralled the support of various groups and lawmakers from both parties for treatment of PTSD, a condition affecting millions of Americans, especially military veterans who face an outsize risk of suicide. No new therapy has been approved for PTSD in more than 20 years.

“What’s happening is truly a paradigm shift for psychiatry,” said David Olson, director of the University of California Davis Institute for Psychedelics and Neurotherapeutics. “MDMA is an important step for the field because we really lack effective treatments, period, and people need help now.”

Amy Emerson, CEO of Lykos Therapeutics, said the company stood behind the data and the design of its studies, which were developed in consultation with FDA staff members. “Functional unblinding,” in which study participants can determine whether they’ve been given a placebo, often influences research on psychoactive medications because patients are acutely aware of the effects, she said.

A rejection of the application would shake the nascent field of psychedelic medicine, which has been drawing millions of dollars in private investment. Much of that backing has been predicated on the approval of MDMA therapy, which the FDA granted breakthrough therapy designation, or fast-track review, in 2017.

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