Five Out Of Six Studies On MDMA Show Positive Results, Yet FDA Approval Still Faces Hurdles

The potential of MDMA-assisted therapy (MDMA-AT) for treating post-traumatic stress disorder (PTSD) has garnered significant attention, including many scientific studies that indicate promising results. However, while the majority of the results suggest safety and efficacy, researchers emphasize the need for more robust investigations before MDMA-AT can be broadly adopted.

Promising Results And Significant Findings

As reported by Marijuana Moment, a review published in the Journal of Psychedelic Studies revealed that five out of six studies on MDMA for PTSD showed positive results, with participants in full-dose MDMA treatment experiencing greater improvements on the primary outcome measure. "Participants in full-dose MDMA treatment arms have shown statistically greater improvements on the primary outcome measure (CAPS) in 5/6 studies (83.3%)," the review states. These results are considered encouraging, yet the authors call for further research to solidify these findings.

Long-Lasting Benefits And Minor Risks

The analysis shows that Phase III trials have demonstrated significant and long-lasting effects, with benefits lasting up to a year post-intervention. Additionally, the risks associated with MDMA administration were found to be relatively minor. "MDMA administration has been associated with few serious adverse events across all studies," the authors noted, adding that it appears well-tolerated among healthy volunteers without medical co-morbidities though it may be risky for those with poor cardiovascular health.

Need For Independent Research

Despite the positive results, the report points out that the existing trials were predominantly undertaken by a single organization, the Multidisciplinary Association for Psychedelic Studies (MAPS). This has led to concerns about potential biases. The review calls for future studies to be conducted by independent researchers to mitigate allegiance bias and ensure more objective results.

The paper critiques the design of current studies, noting that many were poorly blinded and had circular designs. The authors express concerns that participants might have withheld negative effects and overreported positive changes due to a commitment to MAPS’ advocacy goals. "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," they wrote.

FDA’s Stance And Legislative Support

The publication of this review coincides with the U.S. Food and Drug Administration (FDA) advisory panel’s recent decision to reject an application to authorize MDMA-AT. Despite this, a bipartisan group of lawmakers and veterans’ advocates have urged the FDA to reconsider. Rep. Morgan Luttrell (R-TX) emphasized the need to acknowledge the scientific evidence. "What we're asking for the FDA to recognize is the science."

So far, a total of 80 members of Congress have expressed their support for authorizing MDMA-assisted therapy, particularly for veterans with severe mental disorders. “We owe it to our veterans and other affected populations to review these potentially transformative therapies based on sound clinical and scientific evidence,” they said a letter to the FDA signed by 18 senators.

The FDA is expected to make a final decision on the issue sometime in August.

Lykos Therapeutics’ Initiative

In response to the ongoing debate, Lykos Therapeutics, formerly known as MAPS Public Benefit Corporation, announced new initiatives to ensure additional oversight if MDMA-AT is approved. This includes establishing an independent advisory board and collaborating with other health facilities to integrate MDMA-assisted therapy into real-world healthcare settings.

"It is critical for the millions of people suffering with PTSD, including veterans and survivors of physical and sexual assault, to have access to a potential new treatment option," stated Amy Emerson, CEO of Lykos Therapeutics.

Cover image made with AI