FDA Poised To Make Historic Decision On MDMA Therapy To Treat PTSD: Here's How Things Stand

The U.S. Food and Drug Administration (FDA) is on the verge of making a historic decision regarding the approval of Lykos Therapeutics MDMA-assisted therapy as a mainstream medical treatment for post-traumatic stress disorder (PTSD). The decision, expected by August 11, could mark a turning point in the treatment of this condition for those who have not responded to conventional therapies. As the decision looms, the debate continues. Here is a brief review of how we got to August 11.

Ongoing Debate: Optimism And Controversy Surround MDMA's FDA Approval

MDMA's journey to potential FDA approval has been fraught with both optimism and controversy. The substance, the active ingredient found in ecstasy, has long been associated with recreational use, but its potential therapeutic benefits have garnered significant attention in recent years. The substance classification as a Schedule I narcotic poses a barrier to research and treatment. In this context, the FDA granted MDMA breakthrough therapy status in 2017. Several studies were carried out with positive results. Lykos Therapeutics, the company behind the majority of the studies, reported that 71% of participants had their PTSD diagnosis eliminated after undergoing the second stage of the trials.

Concerns And Criticisms: The Integrity Of Clinical Trials In Question

Concerns about the integrity of the clinical trials overshadowed the approval process. In March, the Institute for Clinical and Economic Review (ICER) questioned whether Lykos adequately tracked adverse events, particularly instances of suicidal ideation. In a draft report, ICER acknowledges that the MDMA data suggest it would be an important addition to treatment options for PTSD, while questioning whether the published findings tell the full story. A group of more than 70 physicians and researchers involved in the Phase 3 trials issued a formal comment in response to ICER, stating that certain aspects of the trials were “misrepresented” and that several claims amounted to “hearsay.” Yet skepticism was evident during the heated June meeting of the FDA advisory panel, which ultimately recommended rejecting MDMA for therapeutic use and set August 11 as the date for the final decision.

ICER was not the only entity to speak out on the matter. Months later, in early August, a review published in Journal of Psychedelic Studies revealed that five out of six studies on MDMA for PTSD showed positive results, yet noting these trials were predominantly conducted by a single organization, the Multidisciplinary Association for Psychedelic Studies (MAPS), raising concerns about potential biases. “Though many trials demonstrate promising efficacy and safety results for MDMA-AT for PTSD, the literature to date is dominated by poorly blinded, circularly designed studies orchestrated by a single organization with apparent conflicting interests,” wrote study authors.

A Closer Look At MDMA's Potential To Treat PTSD

Beyond controversies, there is a compelling case for MDMA's approval. PTSD is a debilitating condition that affects millions; there has been a significant lack of new treatment options for over two decades. In addition to the results of phase 2, the two Phase 3 clinical trials conducted by Lykos demonstrated promising results, with 67% and 71% of patients who received MDMA no longer meeting the diagnostic criteria for PTSD.

Addressing Concerns

In response to concerns, Lykos has announced plans to create an independent advisory board to guide the development of the therapy and ensure that it meets the highest health care standards. It has committed to rigorous safety protocols and collaborations with other health facilities to integrate MDMA-assisted therapy into real-world settings. In turn, if MDMA is approved, it will be administered under strict supervision, with therapy sessions led by two mental health professionals.

Bipartisan Support And Veterans' Perspective On MDMA Therapy

While the debate over the testing continues, proponents of MDMA-assisted therapy, including many veterans, argue that the drug has helped them overcome severe PTSD symptoms. Some find approval to be crucial in view of the veterans’ suicide crisis and importance of these therapies that offer a new avenue of treatment for those who have exhausted other options.

This potential breakthrough has garnered bipartisan support in Congress, with over 70 lawmakers urging the Biden administration to greenlight MDMA-assisted therapy.