Tier-1 Medical Journal Publishes Final Results Of Phase 3 MDMA-Assisted Therapy Study
The psychedelic sector received a material boost today, when late this morning, final MAPP2 MDMA-assisted therapy results were published in Nature Medicine. With positive efficacy and safety results in hand, MAPS Public Benefit Corporation is poised to file the first New Drug Application in the industry’s history in the coming weeks. The readout marks the second successful Phase 3 study in the industry, following associated MAPP2 data in January.
In the end, the study proved to show robust efficacy and safety data which will likely play well with regulators. The study demonstrated that MDMA-assisted therapy yielded a substantial clinical improvement in PTSD symptoms for 86.5% of participants after 18 weeks from the baseline and 71% remission rate in general. The latter was, in fact, an improvement over the 67% full remission rate published in January.
The report further reported that significant symptom improvements for patients undergoing MDMA-assisted psychotherapy, as measured by the Clinician-Administered PTSD Scale (CAPS) for DSM-5 (CAPS-5) total severity score (least squares mean change -23.7 vs -14.8; P<0.001).
In other words, the report found that patients who underwent this therapy had significantly greater improvements in their symptoms compared to those who didn’t, with a difference in the scores of -23.7 for the MDMA-assisted therapy group and -14.8 for the other group. The “P<0.001” indicates that this difference is statistically significant, meaning it’s very unlikely to have occurred by chance. Essentially, it’s saying that MDMA-assisted psychotherapy seems to be more effective in reducing symptoms of PTSD compared to other treatments.
CAPS is a structured clinical interview used by mental health professionals to assess and diagnose post-traumatic stress disorder (PTSD) in individuals. It is considered one of the gold standard tools for evaluating PTSD and is widely used in both clinical and research settings. The scale is ultimately designed to provide a systematic and reliable way to assess the presence and severity of PTSD symptoms according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association.
Furthermore, the study showed an enhancement in clinician-assessed functional impairment, as indicated by the Sheehan Disability Scale (SDS), for those who received MDMA-assisted therapy compared to those who received placebo with therapy (least squares mean change -3.3 vs -2.1, P=0.03), as detailed in Nature Medicine.
SDS is a self-report questionnaire used in clinical and research settings to assess the functional impairment and disability experienced by individuals with various mental health disorders. It was developed by Dr. David V. Sheehan, a psychiatrist known for his work in the field of psychiatric assessment and measurement.
Strong Safety Profile
Although there were seven participants that had severe treatment emergent adverse events (TAEA) versus three in the placebo arm, the journal reported none were considered “serious” and no deaths were reported.
Safety is always a critical consideration for the FDA when approving a drug because it is central to protecting the health and well-being of patients. Even after approval, ongoing safety monitoring and reporting are essential components of the organization’s commitment to safeguarding public health.
Overall, these findings corroborated earlier research demonstrating the effectiveness of MDMA-assisted therapy in alleviating PTSD symptoms. Notably, this trial stood out due to its diverse patient population, as highlighted by the report’s authors.