In the wake of groundbreaking studies that have chartered the pathway for international regulatory agencies approval of MDMA assisted therapy (MDMA-AT) for patients with PTSD, concerns of drug safety and administration rise in tandem with mounting excitement for newfound patient care potential. In consideration of the burgeoning trajectory of psychedelics including MDMA toward mainstream clinical adoption, healthcare professionals give praise to the promises offered by MDMA-AT while offering heed to hurdles that may arise with the treatment in a recent article published by The Journal of European Neuropsychopharmacology.
Key points emphasized in the article include:
- By increasing the availability of MDMA-AT, potential advantages for patients with chronic and severe PTSD include sweeping improvements in quality of life and decrease rates of death.
- Increased availability of MDMA-AT for eligible patients with PTSD may also significantly improve US healthcare system spending, with net savings projected to reach up to 266 billion dollars over the course of 10 years.
- Regulatory approval of MDMA-AT for the treatment of PTSD may be granted in the European Union by 2026. In America, regulatory approval may arrive as early as 2025.
National United States and Canadian studies have estimated PTSD rates of approximately 6 to 9 percent in the general adult population. For those who have suffered from any of the multitude of traumatic events that are linked to PTSD, such as those stemming from violence, loss of a loved one, and accidents causing injury or death to another, the chances of developing PTSD are as high as 56.3 percent. Such factors have levied an enormous socioeconomic burden on patients and healthcare systems as a whole.
The Multidisciplinary Association for Psychedelic Studies (MAPS) has been the global frontrunner of clinical MDMA-AT research for the last two decades, achieving groundbreaking results in trials examining the use of MDMA-AT for patients with severe PTSD. These studies include the first Phase 3 clinical trial to examine the effect of MDMA-AT in PTSD patients, in which two thirds of PTSD patients receiving MDMA-AT were found to no longer meet the criteria for a PTSD diagnosis following treatment. Following completion of a Phase 3 trail, results obtained may be submitted to the U.S. Food and Drug Administration (FDA) in a ‘new drug application,’ which if approved, allows the drug to be marketed for use in clinical settings.
MAPS has now completed its second successful Phase 3 study of MDMA-AT for patients with severe PTSD, again reporting top-of-the-line results and a plan to submit a new drug application to the FDA during the third quarter of 2023. Regulatory approval for MDMA-AT in eligible PTSD patients is projected to be granted within one and a half years following submission.
Challenges facing MDMA-AT following approval
Patient eligibility for MDMA-AT is a subject of healthcare professional concern. Risks of MDMA-AT increase when administered to patients with conditions predisposing them to abuse or triggering of psychiatric disorders. Risks of adverse patient experiences following MDMA-AT also increase when administered in non-certified treatment centers without properly defined safety screenings for patients that are not appropriately monitored by trained healthcare specialists.
To mitigate the number of negative patient experiences following widespread approval of MDMA-AT for PTSD, authors suggest that treatment administration must be retained to certified treatment centers with defined safety screenings and a centralized pharmacy. All such measures increase the ability to control for any potential adverse patient outcomes and ensure greater predictability of treatment results.
The training of therapists to provide MDMA-AT under supervised conditions was highlighted as integral for reducing the potential harms resulting from treatment. Though costly and logistically challenging, the benefit of such training is projected to be offset by its advantages. A recent study indicated that increasing MDMA-AT to 25-75 percent of eligible patients with chronic and severe PTSD could save the lives of up to 160,000 patients while leading to savings up up to 266 billion dollars (USD) for the US healthcare system.
Efforts by MAPS have been integral in driving study results that have helped to herald MDMA as the ‘most promising novel adjunctive agent for PTSD psychotherapy.’ Though such results may immediately appear alluring, it is of importance to examine them with scrutiny. Medical research concerning the merits of psychedelic substances including psilocybin and ketamine for treatment of severe mental health disorders has been noted to be largely driven by corporate interests. In tandem with this trend is the observation of lowered standards by peer-reviewed medical journals in relation to publications concerning clinical trials of psychedelics. If we are to see the adoption of MDMA and other psychedelics as adjunctive measures for patient care to widespread fruition, then preservation of research standards and conditions of their therapeutic administration is of utmost importance.