Sixteen out of twenty subjects have completed the double-blind protocol in Dr. Michael Mithoefer’s flagship MAPS-sponsored FDA Phase 2 study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder (PTSD). Three new subjects have been enrolled, two of which are close to completion of the first stage of the protocol. One of these new subjects is a US military veteran whose trauma occurred during combat in Iraq.
Last month, MAPS and Dr. Mithoefer submitted a protocol amendment to FDA, seeking approval to treat a 21st subject, also a US veteran with PTSD from the Iraq War. We need FDA permission to deviate from our inclusion criteria that requires all PTSD subjects to be treatment-failures from both drug and non-drug treatments. The FDA has accepted our request, which we have just submitted to our institutional review board (IRB) for final review.