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.toggle captionThe psychedelic drug MDMA, which has been studied as a possible mental health treatment, may finally get a chance to enter mainstream health care.
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. Representatives of Lykos emphasized the positive findings in clinical data collected during two nearly identical randomized controlled trials.
Another potential sticking point could be the lack of data about how patients experienced the acute effects of the drug, including feelings like “euphoria” or “elevated mood.” That data helps inform the FDA’s assessments of the drug’s abuse potential. However, the FDA staff highlighted various issues with that long-term data, including a dropout rate of 25% and the fact that some participants sought therapy and, in some cases, used illicit drugs, including MDMA..The majority of those in the study had a history of suicidal ideation in their lifetime, but during the study period “the frequency of these symptoms was comparable between the two groups, said Dr. Alia Lilienstein, senior medical director for Lykos Therapeutics.
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