We have learned that the data being generated from the Swiss and Israeli MAPS-sponsored studies will be accepted by the US FDA.
Although these protocols do not need to be approved by the FDA to be conducted in their home countries (they have already been approved by their home country’s regulatory agency equivalent to FDA and by local ethics committees), FDA review and approval enables us to submit to FDA the data from these two studies as part of MAPS’ Investigational New Drug (IND) application for MDMA-assisted psychotherapy in the treatment of PTSD. The data from these studies will be used to help negotiate with FDA regarding the design of larger Phase 3 studies intended to gather data to determine whether or not MDMA meets the requirements necessary to be approved as a legal prescription medicine.
To learn more about the MAPS-sponsored study in Israel evaluating MDMA-assisted psychotherapy for subjects with war- and terrorism-related PTSD, the protocol is posted on the MAPS Web site.
To learn more about the MAPS-sponsored MDMA/PTSD study in Switzerland, the protocol is also posted on the MAPS Web site.