FDA rejection of MDMA-assisted therapy rattles advocates but doesn’t spell end of psychedelics in medicine, experts say
CNN
The path toward federal approval for medical treatments involving psychedelics may be longer and less straightforward after the US Food and Drug Administration denied the first application for a treatment in this category, but experts say the work is far from over.
The path toward federal approval for medical treatments involving psychedelics may be longer and less straightforward after the US Food and Drug Administration denied the first application for a treatment in this category, but experts say the work is far from over. On Friday, the FDA declined to approve the use of MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder, according to a news release from drug sponsor Lykos Therapeutics. The company says the agency has requested an “additional Phase 3 trial to further study the safety and efficacy” of the treatment. The initial application from Lykos presented positive data from two late-stage clinical trials that used MDMA in combination with talk therapy to treat PTSD. But in June, an independent FDA advisory committee voted overwhelmingly against the treatment, citing concerns about the integrity of the particular trials up for review – notably regarding missing information about safety and bias in efficacy data. The advisers said it was also difficult to parse how much the accompanying talk therapy — an area that the FDA does not regulate — contributed to outcomes. Lykos said Friday that it plans to seek a meeting with the FDA to discuss its recommendations and ask the agency to reconsider, confident that the concerns raised by the FDA and its advisers can be addressed. Otherwise, conducting the additional trial could take years, Lykos said. Advocates for the treatment, including some veterans groups, said they were “incredibly disappointed” by the FDA decision. “While we remain confident MDMA-AT will eventually be approved, there is no doubt that this decision will lead to more unnecessary suffering and lives lost,” Martin Steele, president of the Veteran Mental Health Leadership Coalition, and Reason for Hope Executive Director Brett Waters said in a statement.
