F.D.A. Approves New Phase 3 Studies for Ecstasy as PTSD Treatment
The Food and Drug Administration has given approval to Phase 3 clinical trials of MDMA (ecstasy) for the treatment of post traumatic stress disorder (PTSD). This is the final step before the potential approval of ecstasy as a prescription drug.
The move comes after several successful Phase 2 studies of ecstasy, which included 130 PTSD patients. These were conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS). The new research will include at least 230 participants and will also be conducted by MAPS.
The trials already conducted focused on treating those with PTSD who had not responded to traditional prescription drugs or psychotherapy. In one of the studies, after three doses of MDMA administered under a psychiatrist’s guidance, patients reported a 56% decrease in symptom severity. By the end of the study, two-thirds no longer met the criteria for having PTSD.
“We can sometimes see this kind of remarkable improvement in traditional psychotherapy; but it can take years, if it happens at all,” says Dr. Michael C. Mithoefer, psychiatrist involved in the research. “We think it works as a catalyst that speeds the natural healing process.”