Psychedelic drug MDMA faces questions as FDA considers approval for PTSD

This photo provided by the Center for Psychedelic Therapy Research shows a Yehuda Lab MDMA-assisted therapy treatment room at the James J. Peters Department of Veterans Affairs Medical Center in the Bronx borough of New York.

Post-traumatic stress disorder is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans. Currently antidepressants are the only FDA-approved drugs for the condition.Louisiana governor signs bill making two abortion drugs controlled dangerous substances

In two MAPS studies, patients received MDMA as part of an intensive, four-month course of talk therapy lasting more than a dozen sessions, only three of which involved taking the drug. The drug is thought to help patients come to terms with their trauma and let go of disturbing thoughts and memories.

But FDA reviewers noted that the vast majority of patients correctly guessed whether they had received MDMA or a dummy pill, making it “nearly impossible” to maintain the so-called “blinded” objectivity considered essential for high-quality drug research. The agency also questioned how long the drug’s benefits might last.

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