A federal agency may soon approve the use of MDMA, also known as ecstasy, to help treat post-traumatic stress disorder (PTSD).
Advocates and lawmakers across the political spectrum are optimistic about its chances for approval and pushing for a speedy rollout of so-called “MDMA-assisted therapy,” which they say could finally reduce the more than 6,000 veterans who die by suicide each year.
“Having served our Nation in combat I keenly understand the toll it takes on a Service Member’s mental health. We need an ‘all hands on deck’ approach to the suicide crisis impacting Service Members and Veterans,” wrote Rep. Jack Bergman (R-Mich.), a retired lieutenant general in the United States Marine Corps, in a statement to The Hill.
Rep. Lou Correa (D-Calif.), who relaunched the Congressional Psychedelics Advancing Therapies (PATH) Caucus with Bergman at the start of the 118th Congress, told The Hill that MDMA-assisted therapy “promises to be a game-changer for our society.”
“Not only in terms of cost-effectiveness, but more importantly, because this stuff seems to work,” Correa said.
Lykos Therapeutics said Friday the Food and Drug Administration (FDA) had accepted its application seeking approval for MDMA-assisted therapy to treat PTSD and granted the application a “priority review.” The company expects the agency, which designated MDMA-assisted therapy as a “breakthrough therapy” in 2017, will announce its decision on Aug. 11.
An FDA spokesperson said the agency “cannot confirm or deny” the status of pending applications.
While FDA approval is not certain, initial studies have shown MDMA may be effective in treating people who have PTSD when taken in a safe setting and combined with therapy.
The Multidisciplinary Association for Psychedelic Studies (MAPS) — a 501(c)(3) nonprofit that shares ownership of and has “notable” oversight authority over Lykos, including the appointment of six of the company’s eight board members — has been a leader in the study of MDMA-assisted therapy.
In a phase 3 clinical trial of 89 participants conducted between November 2018 and August 2020, Lykos found 88 percent of participants with severe PTSD saw a “clinically significant” reduction in their symptoms two months after their third MDMA-assisted therapy session, compared to 60 percent of patients who received a placebo.
The same study found 67 percent of participants no longer met the criteria for PTSD two months after the treatments, compared to 32 percent in the placebo group.
Published in the Journal of Clinical Pharmacology in April 2022, a separate study by researchers who declared no conflicts of interest also found that MDMA-assisted therapy was “generally safe and well tolerated,” although bruxism, anxiety, jitteriness, headache and nausea were reported following treatment.
These results represent real promise for veterans who suffer from PTSD, advocates say. Nearly 6,400 veterans died by suicide in 2021, 114 more than in 2020, according to the VA’s annual report published in November.
“This number has remained steady since 2005. It’s more veterans than we lost in 20 years of combined combat in the global war on terror,” said Juliana Mercer, director of veteran advocacy and public policy at Healing Breakthrough, an advocacy group dedicated to advancing MDMA-assisted therapy for veterans with PTSD.
Mercer said she has been “surprised and overwhelmed” by the positive response she has received when discussing the issue with members on Capitol Hill, which she attributed to “the fact that we’ve been trying to solve this problem for a really long time and just hitting our heads against the wall with not being able to find a solution.”
The Department of Veterans Affairs (VA) announced last month that it would fund new research into the potential use of certain psychedelics including MDMA to treat veterans suffering from mental health conditions.
“Growing evidence from preliminary research suggests these compounds could offer significant benefits in mental health treatment,” Gary Kunich, a spokesperson for the VA, told The Hill.
But “more definitive evidence from Veterans who use VA healthcare is needed,” he added, as the current studies involved “a very small number of Veterans” and the VA is looking “to determine the effectiveness of psychedelic assisted therapy in a broader diverse population of Veterans” through further research.
When asked if he had any reservations about MDMA-assisted therapy, Bergman said, “I have reservations about the dozens of Veterans who take their lives every day in this country. It’s unacceptable to sit back and not do anything.”
Kunich said the first of three funding cycles is expected to drop after a peer review process in August, when the FDA is expected to announce its decision, and noted that clinical trials can range from two to five years.
But “research has shown that the safety risks of MDMA are low, and the reward is massive: significant reductions in symptoms of PTSD, and even remission,” said Dr. Leonardo Vando, a board-certified psychiatrist and medical director of Mindbloom, a mental health company that utilizes ketamine therapy to treat anxiety and depression.
“With any medical treatment, there’s a balance of risk and reward,” he added. “We know the risk of not adequately supporting our veterans — it’s over 6,000 veteran suicides every year.”
Mercer and Bergman both urged the VA to spin up operations to immediately begin administering MDMA-assisted therapy upon FDA approval.
Bergman said the VA “needs to continue to ramp up its training and capacity to ensure a quick transition once approval is given to MDMA.”
“We can’t have Veterans who are suffering waiting for the VA bureaucracy to get its act together — we need the VA to be ready to provide widespread access to Veterans who are candidates for this new therapy,” he added.
Correa, however, suggested it would be “very easy to ramp up third-party vendors” once they are trained and authorized to administer MDMA-assisted therapy.
There’s already significant investment in biotechnology start-ups that aim to use psychedelic drugs to treat mental health conditions. Companies marketing MDMA, psilocybin mushrooms and other psychedelics as mental health treatments raised at least $163 million across five deals last month alone, the Financial Times reported.
Vando told The Hill that Mindbloom is “incredibly excited” to offer MDMA therapy, but he said it’s “unclear” what guardrails the FDA will put in place that would shape a specific treatment plan.
Another challenge could be changing decades of entrenched stigma.
“We’ve had, you know, 70 years plus public policy of just say no, just say no. And what it’s done is it’s really barred us from considering other therapies that may have to do with things like MDMA, and it’s really cost us,” Correa said.
“Now that we’re turning the ship around, the supertanker’s slowly turning, those are preconceived notions that are hard to break,” he added. “I think we are about to change attitudes. And more importantly, we’re about to bring what appears to be a real cure to a lot of mental challenges in our society.”
Updated at 10:06 a.m.