The Washington Post (6/4, A1, Gilbert , Ovalle ) reports, “A U.S. Food and Drug Administration advisory committee overwhelmingly voted Tuesday that evidence is lacking that MDMA-assisted therapy is effective for treating post-traumatic stress disorder, and that the benefits don’t outweigh the risks to patients, dealing a potential blow to what could be the first psychedelic treatment the agency approves.” The panel’s “vote is not binding. Still, its recommendation could hold great weight as the FDA decides for the first time whether the mind-altering compound – better known by its street name, ecstasy, and long categorized among the riskiest of controlled substances – can be legally used as a medical treatment in the United States.”
The AP (6/4, Perrone ) reports the advisory panel “voted 10-1 against the overall benefits of MDMA 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.” Committee members “pointed to flawed studies that could have skewed the results, missing follow-up data on patient outcomes and a lack of diversity among participants.” Because the drug “causes intense, psychological experiences, almost all patients in two key studies of the drug were able to guess whether they had received the MDMA or a dummy pill. That’s the opposite of the approach generally required for high-quality drug research, in which bias is minimized by ‘blinding’ patients and researchers to whether they received the drug under investigation.”
The New York Times (6/4, Jacobs ) reports the drug’s sponsor, Lykos Therapeutics, “submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy.” However, on Friday, FDA staff “raised concerns about ‘significant increases’ in blood pressure and pulse rates among some of the participants in the Lykos clinical trials, noting those were risks that could ‘trigger cardiovascular events.’”
Reuters (6/4, Roy, Jain) reports that during the meeting, FDA staff “said there was a ‘striking lack’ of documentation of abuse related adverse events, which may limit the agency’s ability to explain the effects of MDMA or determine its abuse liability.”
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