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In a blow to the burgeoning field of psychedelic treatments, advisers to the U.S. Food and Drug Administration voted overwhelmingly against an MDMA-based therapy for PTSD on Tuesday. The panel, with a resounding 10-to-1 vote, determined that the treatment’s benefits did not outweigh its risks. Additionally, nine members expressed doubts about the therapy’s effectiveness based on the available data.

The panel’s deliberations were rife with concerns about the trial methodologies and the reliability of the collected data. “It’s like a game of Jenga with the data – one or two pieces missing might be fine, but when the whole tower’s wobbling, you’ve got problems,” quipped Melissa Barone, a panel member who voted against the treatment.

While the FDA is not obligated to heed the panel’s advice, it typically does and is expected to reach a final decision by August.

MDMA, commonly known as ecstasy or molly, has been championed by some as a promising treatment for mental health disorders, offering potential beyond its notorious party drug reputation. The rejected treatment, a capsule form of MDMA developed by Lykos Therapeutics, was designed to be used in conjunction with talk therapy sessions administered by licensed mental health providers.

Despite the hopeful buzz, notable organizations such as the Institute for Clinical and Economic Review (ICER) and the American Psychological Association had previously deemed the evidence supporting MDMA-assisted PTSD treatment as “insufficient.” An ICER report also flagged concerns about inappropriate therapist behavior during a mid-stage study, an issue that troubled many panelists.

Adding to the skepticism, staff reviewers noted on Friday that the distinctive effects of MDMA made it obvious to patients whether they were receiving the drug or a placebo, thereby skewing the trial results.

The FDA highlighted a “striking lack” of documentation regarding abuse-related adverse events, complicating the agency’s assessment of MDMA’s safety profile. “Supporting something with this many reported harms would be irresponsible,” remarked patient representative Elizabeth Joniak-Grant.

Nonetheless, more than 190 patients who received MDMA in conjunction with therapy experienced a significant reduction in PTSD symptoms compared to those given a placebo.

“We are disappointed in today’s vote given the urgent unmet need in PTSD,” said Lykos CEO Amy Emerson (NYSE) in a statement.

PTSD affects 13 million Americans, with a high prevalence among war veterans. For now, the quest for an effective MDMA-based treatment faces a challenging path forward.