Annual MDMA Report Submitted to the FDA

On Dec. 9, 2010, MAPS’ clinical research team submitted our annual report about MAPS’ MDMA/PTSD research to the FDA. Annual reports are designed to give the FDA an overview of completed, ongoing, and planned studies for specific Investigational New Drug (IND) Applications. In our report, which covered all study activity between June 22, 2009, and October 1, 2010, we provided information about enrollment, including the total number of subjects enrolled for each study. Demographic information for all subjects (such as height, weight, race, and cause of PTSD) was included. We also created overview charts of all serious and severe adverse events experienced by the subjects. Although we reported four serious adverse events to the FDA (a fractured clavicle due to auto accident, a fainting episode, a complication due to cancer, and one psychiatric hospitalization), none of them were related to the administration of MDMA.