Study participants demonstrated a durable response at least six months, and in some cases a year or more, after their final MDMA-assisted therapy session during the Phase 3 study.
MAPS PBC says its findings are consistent with previously published Phase 2 data on the sustained effect of MDMA-assisted therapy for the treatment of PTSD
In two Phase 3 studies, participants who received therapy with MDMA showed significant improvement over therapy with placebo when measured at two months after the last experimental session, meeting the primary and secondary endpoints.
Following the final treatment session, participants went back to their daily lives and then were able to participate in this long-term follow-up study by agreeing to complete an assessment at least six months after their last therapy session with MDMA or placebo.
The primary objective of this study was to evaluate the long-term effectiveness of MDMA-assisted therapy for the treatment of PTSD as measured by the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score.
“PTSD is a chronic condition when insufficiently treated and has historically been addressed through long-term maintenance treatment, which is why it’s important to evaluate whether an acute treatment like MDMA-assisted therapy has an enduring response when used to treat PTSD,” said Amy Emerson, chief executive officer, MAPS PBC. “These results are consistent with previously published Phase 2 data demonstrating the sustained effect of MDMA-assisted therapy at least 12 months following treatment and suggest the acute treatment effect could last even longer.”
Follow-up data continues to be collected from participants. Results also showed the effects of treatment were maintained in participants who were followed up within a year as well as those who were followed more than a year later.
There was also a low incidence of relapse following treatment response or loss of PTSD diagnosis, and an even lower incidence of relapse following remission.
