Bipartisan Letter to President Biden Highlights Promise of MDMA Therapy for PTSD

In a letter addressed to President Joe Biden, bipartisan lawmakers from the House and Senate led by Congress member Jack Bergman, US Representative of Michigan’s First District, highlighted the critical issue of posttraumatic stress disorder (PTSD) and the alarming suicide epidemic among veterans and service members. The letter emphasized the pressing need for innovative and effective treatment options, focusing on therapeutic methylenedioxymethamphetamine (MDMA).

Findings from the phase 3 trials revealed that 71.2% of participants no longer qualified for a PTSD diagnosis after 3 8-hour sessions of MDMA-AT.

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With the FDA decision on MDMA-assisted therapy (MDMA-AT) for individuals with PTSD expected later this week, Bergman and 60 other members of Congress hailed MDMA-AT as a promising solution.

Since 9/11, nearly 150,000 veterans have taken their lives; this total is 21 times the number of American lives lost in war zones in the same time period, the letter stated. While rates of veteran suicide may underestimate the reality, it has been reported that 17 to 44 veterans take their lives each day.

“PTSD and suicide have been exponentially more lethal for those who served in uniform than combat,” the members of Congress wrote. “Despite billions of federal dollars spent on addressing PTSD and mental health, the number of Veteran lives lost to suicide has not decreased. This is due in part to the fact that the FDA has not approved any new treatments for PTSD in nearly 25 years. This astounding lack of innovation has undoubtedly contributed to our rising Veteran suicide rates over the past two decades.”

In June, an independent FDA advisory panel rejected the use of MDMA-AT for PTSD, citing concerns about clinical trial data reliability and determining that the benefits do not outweigh the risks.² However, the FDA can choose not to follow the panel's recommendation.

The new drug application (NDA) for MDMA capsules (Lykos Therapeutics) is based on phase 3 studies showing significant improvements in PTSD symptoms without serious adverse events. Panelists raised issues regarding trial design, potential cardiovascular effects, bias among study facilitators, and the lack of data on drug abuse potential. The application, accepted for priority review, heightened ongoing debates about the regulatory approach to psychedelic therapies, with some experts advocating for revised clinical research requirements.

However, many experts and organizations, including Brian Dempsey, the government affairs director at the Wounded Warrior Project, and Brett Waters, an attorney and cofounder and executive director of non-profit advocacy group Reason for Hope, have advocated for the benefits of this innovative approach to treating PTSD.³

With the FDA’s decision looming, Bergman wrote to the president that “fortunately, hope is on the horizon."¹

“Promising new treatments like MDMA-assisted therapy (MDMA-AT) have the clinically proven potential to bring Veterans who have long suffered with PTSD a treatment that works,” the letter read. “MDMA-AT has shown enormous promise in privately funded research for decades and was officially designated a ‘Breakthrough Therapy’ by the FDA in 2017.”

Findings from the phase 3 trials revealed that 71.2% of participants no longer qualified for a PTSD diagnosis after 3 8-hour sessions of MDMA-AT. Additionally, 86.5% of participants experienced clinically significant improvements in their PTSD symptoms. The letter highlighted that these numbers are almost double those of existing PTSD treatments, making MDMA-AT the most effective PTSD treatment to be developed.

“It is not our intent to urge the FDA in any direction related to its decision, which must be based solely on the data and evidence,” the members of Congress wrote. “However, we are aware that as this application has made its way through the regulatory review process, certain groups and individuals have voiced criticism of the application.”

Acknowledging that public opinion is valid and that some criticisms of the application may be well-intentioned, the letter explained that these criticisms stem from personal ideological beliefs or biases rather than scientific evidence. Public opinions are valid, scientific evidence should not be overshadowed, especially when it concerns the well-being of our service members and veterans.

“Thousands of Veterans suffering from PTSD continue to take their lives each year. Current treatments clearly are not working well enough, and our Veterans can no longer wait,” the letter concluded. “If the data and evidence show that MDMA-AT is safe and effective at relieving the suffering that many Veterans face, then we owe it to them and the millions of others who are living with PTSD to make this treatment option available to them.”

References

1. Bergman J, Correa JL, Luttrell M, et al. Letter to the President. Congress of the United States. August 2, 2024. https://bergman.house.gov/uploadedfiles/mdma_assisted_therapy_letter.pdf

2. Antrim A. FDA advisory panel rejects MDMA-assisted therapy for PTSD. Pharmacy Times^®. June 4, 2024. Accessed August 6, 2024. https://www.pharmacytimes.com/view/fda-advisory-panel-rejects-mdma-assisted-therapy-for-ptsd

3. Kunzmann K. FDA psychopharmacologic advisory committee votes against supporting effectiveness of MDMA for PTSD. HCPLive^®. June 4, 2024. Accessed August 4, 2024. https://www.hcplive.com/view/live-updates-fda-psychopharmacologic-advisory-committee-meeting-mdma-ptsd