MAPS Public Benefit (MAPS PBC) has reported positive topline results from a Phase lll follow-up trial that assessed the long-term safety and efficacy of MDMA-assisted therapy for the treatment of post–traumatic stress disorder (PTSD).

Preliminary data form the observational trial found that the subjects showed a strong response at least six months or a year or more after completing their MDMA-assisted therapy session.

It was also found that the effects of treatment remained intact in subjects who were followed up within a year and those who were followed over a year later.

Incidence of relapse was also minimal after treatment response or loss of PTSD diagnosis, with an even lower incidence of relapse after remission.

In the two Phase lll trials, subjects treated with MDMA-assisted therapy demonstrated significant improvement over patients who received placebo when measured at two months following the last therapy session, thereby meeting the primary and secondary endpoints of the trials.

After the last treatment session, subjects returned to their daily lives and then came back to join the long-term follow-up trial, where they completed an evaluation at least six months after their final therapy session either with MDMA or placebo.  

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By GlobalData

The follow-up trial’s primary objective was to assess the long-term effectiveness of MDMA-assisted therapy to treat PTSD as calculated by the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score.

MAPS PBC CEO Amy Emerson said: “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.

“These results are consistent with previously published Phase ll 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.”