On May 24, 2011, the FDA approved our study of MDMA-assisted psychotherapy for up to three subjects whose PTSD symptoms returned after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. After participating in our initial study, subjects were interviewed using the Clinician Administered PTSD Scale (CAPS), a diagnostic tool used by psychiatrists and researchers to assess the severity of PTSD symptoms. At the two-month follow-up after treatment, over 80% of subjects no longer met the diagnostic criteria for PTSD. In the long-term follow-up (conducted an average of 41 months after treatment) we found that CAPS scores had declined even further, demonstrating that benefits persisted over time. For several of these subjects, however, some symptoms did eventually return. The new study will be limited to these subjects, and is intended to determine whether a single additional open-label MDMA-assisted psychotherapy session can be effective for eliminating these relapse symptoms.
The FDA approval came just one week after the agency received our protocol submission on May 17—the fastest turnaround we have ever seen for an FDA protocol approval. This expediency could be attributable to the fact that the risks of treatment are low: Eligible subjects have already been through treatment and been shown to tolerate MDMA in a clinical context.