MDMA-Assisted Therapy Shows Promise for Treating PTSD in Pivotal Trial, May Lead to FDA Approval
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Phase III trial finds MDMA-assisted therapy effective for treating PTSD, paving way for potential FDA approval.
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Nonprofit MAPS leading research and advocacy efforts for MDMA therapy. Plans to seek formal FDA approval by end of 2023.
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86% of MDMA group had clinically meaningful improvement in PTSD symptoms, vs 69% of control group.
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No major safety issues identified. Common side effects included muscle tightness, nausea, sweating.
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If approved, MDMA therapy could provide new option for PTSD patients unresponsive to existing treatments. More psychedelic-assisted therapies may follow.