Advocates are still fighting to get the psychedelic drug approved as a mental health treatment, despite its rejection by the FDA's advisory committee in June. They face an uphill battle.
Advocates are still fighting to get the psychedelic drug approved as a mental health treatment, despite its rejection by the FDA's advisory committee in June. They face an uphill battle.Controversy has clouded efforts to get MDMA, or ecstasy, approved as a treatment for PTSD. But supporters haven't given up and are lobbying for FDA approval.
The setback threatens to sink the drug’s chances, at least in the short term, and has led Lykos and its allies to redouble their efforts to build public support in the lead-up to the agency’s decision. “It’s so hard for me to speculate,” says Lykos’ Emerson. “But there is no stopping the work on this. We've put decades of time and resources into doing this research.”, a professor of psychiatry and behavioral neuroscience at the University of Chicago who has studied MDMA. “The FDA is faced with a very difficult decision that will set a precedent going forward. “
The centerpiece of the Lykos’ application are two phase 3 clinical trials, which together enrolled about 200 people. The most recent one, published last year, showedno longer met the diagnostics criteria for PTSD after three therapy sessions with MDMA, compared to about 48% who had the same therapy but took a placebo.says those results are “compelling” and the risks were already well-understood — more than 1,500 people have been given MDMA in studies not sponsored by Lykos.
However, many involved with psychedelic research were dismayed by the committee’s hang-up on issues like inadequate blinding of participants.She says it’s hard to tell how much the committee’s opposition was rooted in an “overly conservative” approach because of MDMA’s status as an illicit drug rather than legitimate concerns about lack of clinical benefit.I would just advocate for data-driven decision making that doesn’t exceptionalize psychedelics in ways that aren't justified,” she says.
The form of therapy used in MDMA sessions, which was developed by MAPS, has faced criticism that it can lead to abuses of power when patients are under the influence and vulnerable to suggestion.
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