In August 2024, the U.S. Food and Drug Administration (FDA) published an extensive briefing document regarding MDMA-assisted therapy for post-traumatic stress disorder (PTSD). This was prompted by the application from Lykos Therapeutics (formerly MAPS) to officially approve the treatment as a medicine.
The FDA experts reviewed the Phase 3 studies by Mitchell and colleagues. Despite the positive results — a large proportion of participants no longer met the criteria for PTSD after treatment — the committee identified significant methodological issues. The main objection concerned blinding: participants and therapists could almost always distinguish whether someone had received MDMA or a placebo. This undermines the validity of the outcomes.
In addition, the committee had concerns regarding participant selection, reliance on a specific therapy protocol, the reporting of side effects, and signs of potential transgressive behavior within some research settings.Based on this assessment, the committee recommended by a majority vote to reject the application. The FDA followed this recommendation. Important to note: the rejection does not mean that MDMA-assisted therapy does not work. It means that better, standardized, and more transparent research is needed before regular approval can follow.
The decision has indirect consequences for the European and Dutch situation. FDA approval was often a stepping stone to broader clinical availability. Now, it will take longer for MDMA therapy for PTSD to become available in a regulated setting — although the research will continue.