MAPS Public Benefit Corporation has recently unveiled phase 3 data, marking a significant milestone in its quest for FDA approval of MDMA as a potential treatment for post-traumatic stress disorder (PTSD) in the United States, with the goal of securing approval next year. This achievement follows a decades-long endeavor by the Multidisciplinary Association for Psychedelic Studies (MAPS), which established MAPS PBC in 2014 in anticipation of this momentous event. Earlier this year, the organization reported the successful results of its first phase 3 study, which demonstrated that MDMA, when used in conjunction with supportive therapy, can effectively alleviate PTSD symptoms and functional impairment.
Now, more than two years after the initial release of phase 3 data, MAPS PBC has shared the outcomes of its second pivotal trial, which have been published in Nature Medicine. Encouragingly, these latest findings closely align with those of the earlier study.
In this second phase 3 trial, approximately 100 individuals diagnosed with moderate or severe PTSD were randomly assigned to receive either MDMA or a placebo, alongside supportive therapy. Over the course of 18 weeks, participants underwent three eight-hour dosing sessions, spaced approximately one month apart. The primary measure of success, assessed using the CAPS-5 PTSD scale, revealed a noteworthy reduction of 23.7 points in the MDMA group, compared to 14.8 points in the placebo group. This significant outcome met the trial’s primary endpoint, further substantiating the therapeutic potential of MDMA. MAPS PBC also identified improvements in secondary endpoints, with functional impairment scores dropping by 3.3 points in the MDMA group, compared to a 2.1-point decline in the placebo group. These results mirrored those obtained in the earlier study and held statistical significance.
Regarding safety, the study noted that five patients who received MDMA experienced severe treatment-emergent adverse events, whereas only two individuals in the placebo group encountered such events. Common side effects associated with MDMA included muscle tightness, nausea, decreased appetite, and excessive sweating. Importantly, most of these adverse effects were transient and of mild to moderate severity.
MAPS PBC is now gearing up to utilize the data from its two phase 3 trials to file for FDA approval by the end of this year. If successful, this timeline would position the organization to potentially secure approval in the following year. Given MDMA’s potential as a groundbreaking therapeutic drug, it may also be eligible for priority review. However, there could be questions raised about the trial process, particularly concerning the blinding aspect, as many participants were able to discern which treatment arm they were in. These questions will likely become part of the broader discussion surrounding the potential approval of MDMA as a PTSD treatment.