On 9 August 2024, the Multidisciplinary Association for Psychedelic Studies (MAPS) received a Complete Response Letter (CRL) from the FDA regarding their New Drug Application (NDA) for MDMA-assisted therapy for PTSD. The verdict? The FDA did not approve the therapy, i.e., full rejection of the NDA.
The FDA’s decision was based on several factors. Primarily, the FDA cited concerns about the long-term safety and efficacy of MDMA-assisted therapy. While clinical trials showed promising results, with significant improvements in PTSD symptoms, the FDA asked for more comprehensive data to ensure the therapy’s benefits outweigh potential risks. Additionally, the FDA requested further information on the manufacturing processes and quality controls for MDMA to ensure consistent and safe production.
“The placebo effect is still the strongest medicine we have…if we want interpertable science on psychedelics, we have to design better clinical trials.” – Dr. Boris Heifets, Stanford University
After the CRL, MAPS issued multiple statements articulating their commitment to addressing the FDA’s concerns; MAPS is currently gathering the additional data requested by the FDA. Despite the rejection, MAPS continues to advocate for the development of MDMA-assisted therapy, emphasizing its potential to provide relief for millions of people suffering from PTSD.
Going forward MAPS plans to (plan details outlined at this link):
- Conduct Additional Clinical Trials: MAPS plans to conduct further clinical trials to gather more comprehensive data on the long-term safety and efficacy of MDMA-assisted therapy. These trials will aim to provide the FDA with the robust evidence needed to demonstrate the therapy’s benefits outweigh potential risks.
- Manufacturing and Quality Control: MAPS will work on enhancing their manufacturing processes and quality controls for MDMA. This includes ensuring consistent production standards and addressing any specific concerns the FDA has about the drug’s quality and safety.
- Regulatory Engagement: MAPS intends to maintain ongoing communication with the FDA to ensure all regulatory requirements are met. This involves submitting additional data and documentation as requested and seeking guidance on any further steps needed to achieve approval. This includes how to deal with the questions around the medicine + integration elements that the FDA flagged as needing additional attention and clarification.
- Advocacy and Education: MAPS will continue to advocate for the potential benefits of MDMA-assisted therapy through public education and policy reform efforts. They aim to raise awareness about the therapy’s potential to help those suffering from PTSD and to build support for its approval and use.
The question I’m left with: was this a step backwards or a necessary pause to assess the state of research related to PAP as a mental health treatment option? Sifting through the data available to me, I tend to agree with the FDA, that is, I think more work is needed to determine both the efficacy and safety of these substances as a treatment protocol. I am hopeful a pathway can be found for PAP, but it is essential that this gets done carefully.
Based on my read of the literature, I am of the opinion that if MDMA gets used in a carefully controlled treatment setting it has the potential to become a useful tool catalyzing meaningful psychological change through “noetic” understanding. However, it is not a silver bullet! In other words, it takes more than the simple ingestion of a substance to treat mental health challenges. Use of medicines to treat things like depression teaches us this lesson well. Based on this, to my eye more work is needed to fully articulate how MDMA-assisted-psychotherpy can be used as a mental health treatment.
So, what? Yes. I’ll get to the point.
Where do we go from here? The research community must clearly demonstrate how (altering a person’s brain chemistry) through the use of MDMA (and any and all other PAP treatments) can be used to increase a person’s long-term well-being. Absent this, we are better off hitting the pause button, for now.
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This post does not constitute therapeutic counseling or advice; the contents of this post are provided as a learning resource. We share the contents hoping that if you are in need of mental health support you will reach out to us directly or to a mental health professional in your area.