Summer 2009 Vol. 19, No. 2 Research Edition
On June 22, 2009, preliminary data from MAPS’ flagship US Phase 2 study of MDMA-assisted psychotherapy in the treatment of PTSD was submitted to the US Food and Drug Administration (FDA). The preparation of the preliminary data was the initial step in preparing MAPS’ first-ever Final Clinical Study Report. Over the next two months the study’s database will go through final review and analysis. From this, MAPS will produce the final clinical study report containing a summary and analysis of all safety and efficacy data collected during the study. Submission of the final study report to FDA is the culminating step in completing a clinical study – this will be a monumental achievement in MAPS history!
The purpose of this process is to create a report acceptable to all regulatory authorities. The document will combine the clinical and statistical description, presentations, and analyses of this study’s data into a single report.
The completion of this study is one small step toward MDMA becoming a prescription medicine for use in psychotherapy.