The Washington Post (8/9, Gilbert , Ovalle , Roubein ) reported that on Friday, the Food and Drug Administration “rejected for now the first attempt to win approval of MDMA to treat post-traumatic stress disorder – a major blow for advocates who for decades have pushed to integrate illegal psychedelic drugs into mainstream medical care.” The agency has “requested another large study, which could take several years to conduct, according to” Lykos Therapeutics. The company “said it plans to contest the FDA’s request, saying it believes the existing data is adequate to prove the drug’s efficacy.”
The New York Times (8/9, Jacobs ) reported that following the FDA’s decision, “supporters of psychedelic medicine were deeply disappointed, and some said they were stunned, having assumed the therapy’s promising data would overcome flaws in the company’s clinical trials, which had been designed in consultation with F.D.A. scientists.” The agency “declined to discuss the decision or release the letter it sent to Lykos outlining its reasoning, citing confidentiality rules.” However, an FDA spokesperson said in a statement that the agency “will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies to address these medical needs.”
The AP (8/9, Perrone ) reported that while disappointing for some, “the FDA’s decision was expected after a panel of government advisors voted overwhelmingly against the drug’s use for post-traumatic stress disorder in June.” The agency “said Friday the MDMA application had ‘significant limitations’ that ‘prevent the agency from concluding that the drug is safe and effective for the proposed indication.’”
Also reporting was Reuters (8/10, Roy, Sunny).
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