The field of psychedelic medicine is on the cusp of a groundbreaking development as the United States could soon approve MDMA therapy. Over the past few years, perceptions about the therapeutic value of once-illicit drugs like ecstasy have shifted dramatically. With increasing evidence supporting the efficacy of psychedelic-assisted therapy, the possibility of FDA approval for MDMA therapy looms, heralding a new era of psychedelic medicine. However, questions and uncertainties remain about what the approval process might entail and what the future holds for this promising field of research.
As per an article featured in Nature, MAPS (Multidisciplinary Association for Psychedelic Studies), a non-profit organization based in Belmont, Massachusetts, has been researching the therapeutic potential of the psychedelic drug MDMA, commonly known as ecstasy or molly, for nearly 40 years, particularly in treating post-traumatic stress disorder (PTSD). In 2021, MAPS’s phase III clinical trial involving 90 individuals with PTSD found that those who received MDMA-assisted psychotherapy were twice as likely to recover from the condition as those who received psychotherapy with a placebo.
Building on this success, MAPS has completed a second, larger trial, yielding positive results. The study is expected to be published in the coming months. MAPS plans to submit an application to the US Food and Drug Administration (FDA) for approval of MDMA as a legal treatment for PTSD, likely by October. If approved, it would mark a significant turning point for psychedelic drugs, which have long been illegal and challenging to study. Rick Doblin, the founder of MAPS, is optimistic about the approval process, stating, “I don’t think there’ll be tricky questions or anything; the results are great.”
This shift towards recognizing the therapeutic potential of psychedelic therapy is not limited to the United States. In February, Australia approved MDMA as a treatment for PTSD, although the drug will remain highly restricted. Doblin and other advocates hope that changing attitudes towards psychedelics will pave the way for other therapeutic uses, including ketamine, ayahuasca, LSD (acid), psilocybin (the active ingredient in magic mushrooms), and other synthetic chemicals currently under development. Some analysts have projected that the psychedelics market could be worth over US$8 billion by 2028.
However, several questions and challenges remain in the short term. One key concern is how MDMA will be administered and by whom. MAPS officials assert that the drug must be given with a specific psychotherapy protocol developed by the organization’s scientists. However, the FDA does not typically regulate specific treatment protocols; it is unclear how this aspect will be addressed in the approval process.
Additionally, it remains uncertain whether approval of MDMA for PTSD by the FDA would facilitate or hinder other companies’ efforts to study and develop the drug, given that MDMA has existed since 1912 and cannot be patented, providing a little financial incentive for further research and development. Furthermore, if any problems arise after the drug is approved, there are concerns that political and public sentiment could turn against psychedelics, potentially setting the entire field back.
Despite these challenges, Doblin envisions a future where treatment centers offering psychedelic-assisted therapies will emerge worldwide, with over 6,000 centers predicted in the United States alone. He hopes for the full legalization of psychedelic substances, allowing individuals to use them for therapeutic purposes as they see fit. “MAPS has been the beacon to take on this work,” says neuroscientist Amy Kruse, Chief Investment Officer at venture capital firm Satori Neuro. “Many people can benefit from this treatment, and I think it shows a pathway for the potential rescheduling of other molecules.” As the field of psychedelic research and therapy continues to evolve, 2023 may be a landmark year with potentially significant implications for treating mental illness.
To address this issue, MAPS worked with the FDA to develop a unique protocol where the efficacy of the treatment is evaluated by psychologists blinded to the participants’ group assignments. However, there are concerns about the guided therapy’s unscripted component and its potential influence on the results. Additionally, safety concerns have arisen, including cases of misconduct by therapists involved in the trials, leading to updated consent forms and stricter guidelines.
In 2022, an US Department of Health and Human Services official anticipated that the FDA would approve MDMA by 2024. The FDA has also granted breakthrough status to MDMA and psilocybin, expediting their regulatory approval process. Organizations such as the American Psychological Association have expressed cautious optimism about the therapeutic potential of psychedelics but emphasize the importance of regulatory approval based on scientific evidence rather than popular opinion.
MAPS continues to sponsor trials to explore different types of psychological co-treatments and further research the therapeutic use of psychedelics. Doblin believes that the results from the trials are not solely due to MDMA but also the skills and training of the therapists administering the treatment. The future of MDMA and other psychedelics as psychiatric treatments will likely depend on the outcome of ongoing research and regulatory decisions.