WASHINGTON – An independent advisory panel to the U.S. Food and Drug Administration has overwhelmingly voted against approving the use of MDMA-assisted therapy for post-traumatic stress disorder, delivering a significant blow to advocates who saw the treatment as a potential breakthrough for millions of patients.

In a day-long public meeting, the FDA's Psychopharmacologic Drugs Advisory Committee scrutinized data from two major clinical trials sponsored by Lykos Therapeutics. Ultimately, the panel voted 9-2 that the available evidence did not show the therapy was effective. In a subsequent vote on its overall risk-benefit profile, the committee voted 10-1 that the treatment's benefits do not outweigh its risks for patients with PTSD.

The panel's recommendation, while not binding, will heavily influence the FDA's final decision, which is expected by August 11. An approval would have made MDMA, commonly known as ecstasy or molly, the first psychedelic-assisted therapy to be legally sanctioned in the United States, potentially paving the way for other compounds like psilocybin.

Scrutiny Over Trial Design and Patient Safety

Panel members raised sharp criticisms regarding the methodology and integrity of the clinical trials. A primary concern was the difficulty in conducting a "blinded" study, where neither the participant nor the administrator knows who is receiving the drug versus a placebo. Panelists argued that the potent psychoactive effects of MDMA made it obvious to most participants which group they were in, potentially biasing their self-reported outcomes.

"It seems like there are so many problems with the data," said Dr. Melissa Decker, a panel member and biostatistician. "Each one alone might be okay, but when you pile them on top of each other, there’s just a lot of questions about the integrity of the data."

Further concerns centered on patient safety and the potential for abuse. The panel reviewed reports of "therapist misconduct" in the trials, including allegations of inappropriate touching and boundary violations. Additionally, they highlighted the lack of long-term data on potential cardiovascular risks and the abuse potential of MDMA itself.

A Setback for a Growing Movement

The decision is a major disappointment for veterans' groups, researchers, and patients who have championed the therapy as a vital new tool for treating severe PTSD, a debilitating condition that is often resistant to existing treatments. An estimated 13 million Americans suffer from PTSD, and current therapies like SSRIs and traditional talk therapy are not effective for everyone.

Lykos Therapeutics, a public-benefit corporation spun out of the Multidisciplinary Association for Psychedelic Studies (MAPS), has been at the forefront of this research for decades. In a statement following the vote, Lykos CEO Amy Emerson said, "We are disappointed in today's vote and the advisory committee's recommendation against the approval of MDMA-assisted therapy for PTSD. We remain committed to working with the FDA to address the committee's concerns."

Advocates argue that the therapeutic protocol—which involves several intensive therapy sessions under the guidance of two trained professionals before, during, and after three MDMA sessions—provides a structured and safe environment. They point to trial results showing a significant reduction in PTSD symptoms for many participants.

What Comes Next?

While the FDA typically follows the advice of its advisory committees, it is not required to do so. The agency could still approve the treatment, reject it, or request that Lykos Therapeutics conduct additional studies to address the panel's concerns.

The panel's vote casts a shadow over the burgeoning field of psychedelic medicine, which has attracted hundreds of millions of dollars in investment in recent years. The outcome of the FDA's final decision will be a critical bellwether for the future of psychedelic drug development and its potential integration into mainstream mental healthcare. For now, a treatment that many hoped was on the verge of becoming a reality faces a deeply uncertain future.