FDA advisors reject MDMA therapy for PTSD, amid concerns over research

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FDA advisors reject MDMA therapy for PTSD, amid concerns over research
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A panel of advisors to the FDA voted against the potential use of MDMA for treating PTSD.

A dose of MDMA. The drug has been studied as a treatment for PTSD and FDA is now considering whether to approve it.

However, that would be especially surprising given the host of concerns raised during the all-day meeting. “We are charting new territory,” said Kim Witczak, a consumer representative on the FDA’s advisory committee. “We want to set it up right.” “Although we do have two positive studies, the results are in the context of dramatic functional unblinding,” says Dr. David Millis, clinical reviewer for the FDA.

While not yet published in a peer-reviewed journal, that data “suggest evidence of MDMA’s durability to at least six months,” said Yazar-Klosinski with Lykos.

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