Criticism of FDA’s Rejection of MDMA Therapy for Trauma Sparks Debate in Psychedelic Community

Criticism of FDA’s Rejection of MDMA Therapy for Trauma Sparks Debate in Psychedelic Community

In a recent announcement on August 9, a drugmaker revealed that the U.S. Food and Drug Administration (FDA) had declined to approve the use of the psychedelic MDMA for psychotherapy in treating post-traumatic stress disorder (PTSD). Lykos Therapeutics, the company that had submitted a new drug application to the FDA, was asked to conduct an additional late-stage clinical trial to further examine the safety and efficacy of MDMA. This decision was met with disappointment from patient advocates and experts in the field of psychedelic therapies.

Jennifer M. Mitchell, a neuroscientist at the University of California, San Francisco, expressed her disappointment, stating, “It’s a true disappointment. From my perspective, I thought we met the criteria that the FDA requested, and I absolutely stand by our data.” Similarly, Stephen Xenakis, a retired brigadier general in the U.S. Army and a psychiatrist, emphasized the urgent need for such treatments, especially for veterans and individuals struggling with despair. He criticized the FDA for what he perceived as a failure to lead in facilitating access to innovative therapies.

The rejection of Lykos’s application by the FDA has ignited a debate within the psychedelic community. While the FDA has not publicly disclosed the contents of the rejection letter, reports indicate that the concerns raised by the agency mirrored those discussed in an advisory committee meeting in June. One major issue highlighted during the meeting was the challenge of distinguishing the effects of MDMA from a placebo, as many trial participants correctly guessed whether they had received the drug or a placebo—a phenomenon known as functional unblinding.

In response to the FDA’s decision, Lykos stated that they had previously addressed the substantive issues raised during the advisory committee meeting. The company emphasized that they had taken steps to minimize the impact of functional unblinding and had discussed the issue extensively with the FDA during the design of the phase 3 trials in 2017. Despite these efforts, the FDA’s decision to request another clinical trial has raised concerns about the future of MDMA-assisted therapy for PTSD.

PTSD affects millions of Americans, with veterans being disproportionately impacted by the condition. The limited effectiveness of existing therapies underscores the urgent need for alternative treatments. In a fiscal year 2021 report, the U.S. Department of Veterans Affairs revealed that up to 10 percent of male veterans and 19 percent of female veterans were diagnosed with PTSD. Tragically, an average of 17 veterans die by suicide each day, further underscoring the critical need for innovative therapeutic approaches.

Prior to the FDA’s decision, bipartisan lawmakers and veterans had urged President Joe Biden to approve MDMA therapy for PTSD. Representative Jack Bergman of Michigan, a retired lieutenant general of the U.S. Marine Corps, expressed disappointment in the FDA’s handling of the matter and vowed to convene a meeting between FDA leadership and Congress to address the issue. The rejection of MDMA therapy has raised concerns about the future of innovative treatments for mental health conditions.

Despite the setback, Lykos intends to request a meeting with the FDA to reconsider its decision and explore alternative pathways for approval. The financial constraints associated with conducting another phase 3 trial pose a significant challenge for the company, raising questions about the feasibility of moving forward with the research. The reliance on philanthropic donations to fund research on MDMA-assisted therapy further complicates the path to FDA approval.

The FDA’s decision to reject MDMA therapy for PTSD was based on data from two phase 3 clinical trials involving nearly 200 participants. Published in Nature Medicine, the studies showed promising results, with more than two-thirds of participants who received MDMA-assisted therapy no longer qualifying for a PTSD diagnosis at the end of the trial. In contrast, a lower percentage of participants who received a placebo alongside talk therapy experienced similar improvements, highlighting the potential efficacy of MDMA in treating PTSD.

The advisory committee’s decision to reject MDMA therapy has sparked criticism from researchers and experts in the field of psychedelics. Many have expressed concerns about the committee members’ understanding of the application and the essential role of psychotherapy in the treatment process. Michael Mithoefer, a clinical psychiatry faculty member at the Medical University of South Carolina, highlighted the extensive collaboration between Lykos and the FDA, emphasizing the unexpected nature of the rejection.

In addition to concerns about functional unblinding, the advisory committee raised issues related to the standardization of psychotherapy across trial sites, participants’ previous exposure to MDMA, and the collection of safety data. Ethical violations involving a therapist’s inappropriate relationship with a trial participant also cast a shadow over the research, leading to retractions of papers analyzing the phase 2 trial. These ethical concerns have raised questions about the integrity of the research and the implications for future studies.

Despite the challenges faced by researchers and regulators in evaluating psychedelic therapies, the potential benefits of MDMA-assisted therapy cannot be overlooked. The promising outcomes observed in clinical trials underscore the need for continued research and exploration of innovative treatment approaches for mental health conditions. While the FDA’s decision has raised uncertainties about the future of MDMA therapy, advocates and researchers remain hopeful that alternative pathways for approval will be explored.

In conclusion, the rejection of MDMA therapy for PTSD by the FDA has sparked a heated debate within the psychedelic community. The decision highlights the complexities and challenges associated with evaluating innovative therapies and underscores the need for a nuanced approach to regulating psychedelic treatments. As researchers and advocates continue to push for access to groundbreaking therapies, the future of MDMA-assisted therapy remains uncertain, but the quest for effective treatments for mental health conditions persists.