Lawmakers, advocates champion MDMA as a ‘game-changer’ in PTSD treatment

Federal regulators may soon approve the use of MDMA, also known as ecstasy, to treat post-traumatic stress disorder (PTSD).

Advocates and lawmakers across the political spectrum are optimistic about the chances of approval and are calling for rapid rollout of so-called “MDMA-assisted therapy,” which would benefit more than 6,000 veterans each year. They claim it could ultimately reduce deaths by suicide.

“As I have served our country in combat, I am acutely aware of the toll it takes on the mental health of our service members.” ’ approach,” said Rep. Jack Bergman (R-Mich.), a retired U.S. Marine Corps lieutenant general, in a statement to The Hill. .

Rep. Lou Correa (D-Calif.), who reinstated the Congressional Advancement of Psychedelic Therapeutics (PATH) Caucus with Bergman at the beginning of the 118th Congress, told The Hill that MDMA-assisted therapy is a “big deal for our society.” “It promises to be transformative.” society. “

“Not only because it’s cost-effective, but more importantly because it seems to work,” Correa said.

Lycos Therapeutics announced Friday that the Food and Drug Administration (FDA) has accepted its application for approval of an MDMA-assisted therapy for the treatment of PTSD and granted the application “priority review.” The company expects the agency, which designated MDMA-assisted therapy as a “breakthrough therapy” in 2017, to announce its decision on August 11.

An FDA spokesperson said the agency “cannot confirm or deny” the status of pending applications.

Although FDA approval is not certain, early research shows that MDMA may be effective in treating PTSD patients when taken in a safe environment and used in conjunction with therapy.

The Multidisciplinary Association for Psychedelic Studies (MAPS) — a 501(c)(3) nonprofit organization. Stock ownership He has “remarkable” oversight authority over Lykos, including appointing six of the company’s eight board members, and is a leader in research into MDMA-assisted therapy.

in Phase 3 clinical trial According to MAPS, which was conducted with 89 participants between November 2018 and August 2020, 88% of participants with severe PTSD experienced 2 or 2 hours from their third MDMA-assisted therapy session. After months, 60% of patients who received MDMA-assisted therapy were found to have a “clinically significant” reduction in symptoms. placebo.

The same study found that 67 percent of participants no longer met criteria for PTSD after two months of treatment, compared with 32 percent in the placebo group.

Published in the Journal of Clinical Pharmacology in April 2022. another study The researchers, who declared they had no conflicts of interest, also found that MDMA-assisted therapy was “generally safe and well-tolerated,” although teeth grinding, anxiety, irritability, headaches, and nausea were reported after treatment.

Advocates say these results show real hope for veterans suffering from PTSD.According to the Veterans Administration, nearly 6,400 veterans died by suicide in 2021, an increase of 114 from 2020. annual report Published in November.

“This number has remained stable since 2005, and is more than the number of veterans lost in 20 years of joint combat in the global war on terror,” said Veterans Advocacy and Veterans Affairs at Healing Breakthrough, an advocacy group dedicated to progress. said Juliana Mercer, director of public policy. MDMA-assisted therapy for veterans with PTSD.

Mercer said he was “surprised and overwhelmed” by the positive response he received when he discussed the issue with lawmakers on Capitol Hill, citing why “we’re going to solve this problem for a really long time.” The fact that we’ve been doing this and not finding a solution, we’re just banging our heads against the wall.”

The Department of Veterans Affairs (VA) announced last month: fund new research It is considering the potential use of certain psychedelics, including MDMA, to treat veterans suffering from mental health conditions.

“A growing body of evidence from preliminary studies suggests that these compounds have the potential to have significant benefits in mental health treatment,” Veterans Affairs spokesman Gary Kunich told The Times. told Hill.

However, the current study involved “a very small number of veterans,” and the Department of Veterans Affairs is considering “determining the effectiveness of psychedelic-assisted therapy in a broader and more diverse population.” “We need more conclusive evidence from veterans who access VA health care,” he added. Through further research, we revealed that “veterans”.

When asked if he had any concerns about MDMA-assisted therapy, Bergman said: “I am concerned about the dozens of veterans who take their lives every day in this country. It is unacceptable for us to sit and do nothing.”

Kunich said the first of three funding cycles is expected to decline after the peer review process in August, when the FDA is expected to announce its decision, and clinical trials will range from two to five years. He pointed out that there is a possibility.

However, “research shows that the safety risks of MDMA are low and the rewards are enormous. PTSD symptoms can be significantly reduced and even remitted,” says Dr. MDMA, a board-certified psychiatrist at Mindbloom Medical Director Dr. Leonard Vand said. A mental health company that uses ketamine therapy to treat anxiety and depression.

“Any treatment requires a balance of risks and benefits,” he added. “We know the risks of not properly supporting our veterans. More than 6,000 veterans commit suicide each year.”

Both Mercer and Bergman called on the Veterans Administration to establish operations to begin administering MDMA-assisted therapy as soon as it receives FDA approval.

Bergman said the Veterans Administration “must continue to strengthen its training and capabilities to ensure a rapid transition once MDMA is approved.”

“Veterans who are suffering cannot wait for the VA bureaucracy to take action. The VA is prepared to provide broad access to veterans who are candidates for this new treatment. must be able to do so,” he added.

However, Correa suggested that it would be “very easy to ramp up third-party vendors” once they are trained and licensed to perform MDMA-assisted therapy.

There is already significant investment in biotech startups that aim to use psychedelics to treat mental health conditions. Companies that sell MDMA, psilocybin mushrooms and other psychedelic drugs as mental health treatments have raised at least $163 million in five deals in the last month alone. The Financial Times reported.

Band told The Hill that Mindbloom is “incredibly excited” to offer MDMA therapy, but is unsure what guardrails the FDA has in place to shape a specific treatment plan. He said it was “unclear” whether there would be a.

Another challenge may be changing prejudices that have been ingrained for decades.

“We’ve had a public policy for over 70 years of just saying no, just saying no. And as a result, we’ve had other treatments that may be associated with things like MDMA. It actually prevented us from considering it and it caused us great harm,” Correa said.

“Now we are turning ships around and slowly turning supertankers, but those are preconceptions and they are hard to break through,” he added. “I think we’re trying to change attitudes. And more importantly, we’re trying to bring what we think are real treatments to many of society’s mental challenges.”