A panel of advisors to the FDA is evaluating 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.
Agency staff focused on uncertainties and gaps in the data, unanswered questions about its potential for abuse and a lack of evidence supporting the psychological approach used in the therapy sessions. For example, one of those studies showed 67% of participants in the MDMA treatment arm no longer met the diagnostic criteria for PTSD following three dosing sessions with MDMA, compared to about 32% in the placebo group who underwent the therapy sessions but did not receive an active drug.
“We noticed a striking lack of abuse-related adverse events,” said Millis, noting that the FDA had advised the study sponsors to collect this type of data.
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