Panel rejects psychedelic drug MDMA as a PTSD treatment in possible setback for advocates

when used to treat post-traumatic stress disorder. They cited flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse.

“The fact that this study has so many white participants is problematic because I don’t want something to roll out that only helps this one group,” said Elizabeth Joniak-Grant, the group’s patient representative.The FDA advisers also drew attention to allegations of misconduct in the trials that have recently surfaced in news stories and aLykos Therapeutics, the company behind the study, said it previously reported the incident to the FDA and regulators in Canada, where the therapist is based.

MDMA doesn't cause the visual hallucinations commonly associated with psychedelics. Instead, its main effect is triggering feelings of intimacy, connection and euphoria. When used to enhance talk therapy, the drug appears to help patients process their trauma and let go of disturbing thoughts and memories.

Panelists also noted the difficulty of knowing how much of patients’ improvement came from MDMA versus simply undergoing the extensive therapy, which totaled more than 80 hours for many patients. Results were further marred by other complicating factors, including a large number of patients who had previously used MDMA or other psychedelics drugs recreationally.

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