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MAPS Phase III Trial Results Mark a Paradigm Shift in Mental Health Treatment

Post-traumatic stress Disorder (PTSD) is a debilitating mental health condition that affects millions of people worldwide. It affects 5% of the US population,…

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Post-traumatic stress Disorder (PTSD) is a debilitating mental health condition that affects millions of people worldwide. It affects 5% of the US population, and viable treatment options are lacking.

MDMA-assisted therapy offers a new glimmer of hope for people suffering from the aftereffects of trauma. The Multidisciplinary Association for Psychedelic Studies PBC, or MAPS, has been pioneering the effort to get this treatment into the hands of the people who need it. Today marks a major milestone in making that happen. 

The psychedelic industry has been biting its time, waiting for the MAPP2 Phase III readout. As the third quarter approaches its end, it is finally here. This morning, the study results were released in the Nature Medicine Journal.

MAPS has been at the forefront of bringing psychedelic treatment to the masses since the very beginning. In fact, the non-profit essentially created the path to FDA approval of psychedelic drugs that many companies are now attempting to follow. It has yet to be proven that this pathway actually leads to the desired destination. However, MAPS just took a major step towards proving that it can.

The mission of MAPS is to develop safe and effective treatments using psychedelics, such as MDMA. While the non-profit has many different clinical trials underway, its development of MDMA-assisted therapy for the treatment of PTSD has been its shining star. With two phase III studies now out, it is clear that this treatment has great potential for helping trauma survivors recover and reclaim their lives. 

The MAPS Phase III Study Readout

The MAPP2 Phase III trial is a significant milestone in the journey toward recognizing MDMA-assisted therapy as a legitimate treatment option for PTSD. The randomized, double-blind, placebo-controlled study involved just over a hundred participants across multiple research sites. The goal of the study— to rigorously evaluate the safety and efficacy of MDMA when combined with psychotherapy for people suffering from moderate to severe PTSD.

Trial Design

The MAPP2 trial had 104 participants. 53 participants received the MDMA treatment, while 51 participants were given a placebo. Both groups underwent therapy sessions in tandem with the dosing. 

Each participant underwent three 90-minute preparation sessions with a two-person therapy team. Then, over a three-month period, they had three dosing sessions where participants either received MDMA or a placebo. Sessions lasted 8 hours, and participants received two doses. The supplemental dose was given approximately 1.5-2 hours after the initial dose. Therapists were there to provide emotional support and guidance throughout the sessions.

Key Findings

The results from the study were extremely positive, and the report said, “These findings confirm and extend the results observed in the MAPP1 study.” 

  • Significant Reduction in PTSD Symptoms: 85% of the group that received the MDMA had significant improvement in their PTSD symptoms 18 weeks after treatment versus 69% of the placebo group. 71.2% no longer met the criteria for PTSD after the MDMA treatment.
  • Low Dropout Rate: In addition to the symptom improvement seen in participants who received the MDMA treatment, the dropout rate was significantly lower compared to the placebo group. The MDMA group had a 1.9% dropout rate, compared to 15.7% in the placebo group. This is significant given that Veterans undergoing treatment for PTSD generally have a high dropout rate.
  • Long-lasting Results: Perhaps one of the most intriguing aspects of MDMA-assisted therapy for PTSD is its sustained effects. Though there are no long-term results from this particular study, a follow-up study from a MAPS Phase II study showed that a high percentage of participants received long-term benefits from treatment.
  • Safety Profile: Adverse effects of the MDMA treatment were generally mild. Though 98.1% of participants experienced at least one treatment-emergent adverse event (TEAE), they consisted primarily of muscle tightness, nausea, decreased appetite, and hyperhidrosis (excessive sweating). No serious adverse effects were reported.

What Does This Mean for the Industry?

The results of the MAPP2 Phase III trial have profound implications for the mental health, psychedelic, and pharmaceutical industries. And, of course, for people struggling with PTSD. 

The success of the trial validates psychedelic-assisted therapy as a legitimate and effective treatment for mental health conditions. For decades, psychedelics have been stigmatized and classified as Schedule 1 substances in many countries. The positive outcomes of this trial challenge the misconceptions and open the door to further exploration of psychedelics for therapeutic purposes. 

The field of mental health treatment has long been in search of effective treatment for PTSD. The conventional approach, which relies on pharmaceuticals and traditional talk therapy, has limitations. 

The MAPP2 trial suggests that MDMA-assisted therapy offers a new paradigm for treating PTSD, one that is potentially more effective and long-lasting. This could pave the way for a shift in how mental health conditions are treated, with a greater emphasis on holistic, psychedelic-assisted therapies. 

For other companies working to bring psychedelic therapies to the masses, the success of MAPS is likely to attract interest and investments from big pharma companies and institutional investors. The potential market for MDMA-assisted therapy for PTSD and other mental health conditions is substantial, and the positive results from this trial provide a strong incentive for further research and development. 

On the regulatory side of things, this could influence agencies like the FDA to further support psychedelic drugs. The FDA has already shown interest in psychedelic treatments— granting the MAPS MDMA program breakthrough drug status back in 2017. COMPASS Pathways has also received this status for its psilocybin drug COMP360. 

If these programs are successful, and as more data accumulates supporting the efficacy and safety of the treatments, it may become easier for researchers to navigate the regulatory hurdles necessary for drug approval. 

The MAPP2 Phase III trial results are a monumental step forward in bringing MDMA-assisted therapy to the forefront of PTSD treatment. This groundbreaking study has shown not only the safety of MDMA in a controlled therapeutic setting but also its remarkable efficacy in reducing PTSD symptoms and improving the lives of those who have survived traumatic experiences.

Now that the results have been released, MAPS can submit a new drug application to the FDA by the end of the year. Approval is expected in the first half of 2024, at which time MAPS can begin commercializing MDMA-assisted therapy.

While there is much work ahead, the MAPP2 trial results have set the stage for a paradigm shift in mental health treatment. MDMA-assisted therapy has the potential to transform the lives of people burdened by the weight of PTSD, offering them a path toward healing, recovery, and a brighter future. 

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