A Food and Drug Administration (FDA) panel’s surprising recommendation this week to reject the use of MDMA, commonly known as ecstasy, to treat PTSD was a blow to advocates and lawmakers who champion the treatment as a game changer for mental health in the United States.
The FDA, which designated MDMA-assisted therapy as a “breakthrough therapy” in 2017, is considering an application by Lykos Therapeutics to approve the proposed treatment for PTSD.
The proposed treatment is the first time the U.S. has considered a Schedule I drug — those considered to have a high potential for abuse such as heroin and LSD — for medical use and, if approved, would be the first new treatment for PTSD in several decades.
“I’m disappointed that the FDA advisory committee chose to ignore the voices and testimonies of Veterans whose lives have been forever improved by MDMA-assisted therapy, and instead voted in favor of those who have been on a mission to discredit this promising treatment at all costs,” Rep. Jack Bergman (R-Mich.), a retired lieutenant general in the U.S. Marine Corps, told The Hill.
The panel voted 10-1 to reject the question of whether the risks outweigh the benefits and 9-2 against endorsing its efficacy. Its recommendation is not binding, and the agency is expected to issue its final decision on the treatment by Aug. 11.
Rep. Lou Correa (D-Calif.) called the panel’s decision “dead wrong.”
“This is a first cure that promises to revolutionize psychiatric treatment in like 50, 60 years, and they’re denying it? Are you kidding me?” Correa, who co-chairs the Congressional Psychedelics Advancing Therapies Caucus with Bergman, said in an interview with The Hill.
Recent Phase 3 clinical trials conducted by Lykos showed the treatment had a 71 percent efficacy rating for PTSD. But the panel of independent advisers raised concerns around several issues including the diversity of study participants, potential side effects and the feasibility of a “blind” study involving psychedelics.
“Midomafetamine produces profound alterations in mood, sensation, suggestibility, and cognition. As a result, studies are nearly impossible to blind,” the panel wrote in briefing documents posted before the meeting, noting “functional unblinding can introduce bias in clinical studies.”
Several panelists said that while they were excited by the initial results, they felt the drug was too experimental.
“While we are disappointed in the vote, we are committed to continuing to collaborate with the FDA with their ongoing review,” Lykos CEO Amy Emerson said in a statement following the vote. “There is an urgent need for new, effective and accessible therapies to address this unmet need for those living with PTSD.”
Ahead of the panel’s recommendation Tuesday, Bergman and Correa celebrated the unanimous addition of two amendments to a federal appropriations bill that would push the Department of Veterans Affairs (VA) to expand and prioritize research into MDMA-assisted therapy, training and a plan to incorporate the treatment if it’s approved.
During a fireside chat at a Horizons psychedelic conference in New York City last month, VA Under Secretary for Health Shereef Elnahal said the results of studies on the use of MDMA to treat PTSD “speak for themselves.”
“Here’s the reality. For conditions like PTSD and particularly unique manifestations of PTSD that we see among veterans, the evidence-based therapies that we have, while they help, pale in comparison if we are able to replicate the scale of preliminary results we have seen in the studies for psychedelics, especially MDMA for PTSD, and increasingly psilocybin for treatment-resistant depression. So that is the reason I’m here,” said Elnahal.
Juliana Mercer, director of veteran advocacy and public policy at Healing Breakthrough, told The Hill that she woke up with a knot in her stomach after the decision dropped.
Healing Breakthrough is an advocacy group dedicated to advancing MDMA-assisted therapy for veterans with PTSD. More than 6,000 veterans die by suicide each year, and Mercer said the drug offers real hope for veterans who suffer from PTSD.
“That knot hasn’t left and it’s [a] heartbreak for all the veterans who were looking to this as a hope and light at the end of the tunnel to relief from decades of pain. Those veterans on the waiting list to go out of the country and the veterans who were holding out hope that help was imminent — we are crushed,” Mercer said.
The proposed treatment would help more than just veterans, advocates and lawmakers said. The VA estimates that 5 percent of people in the U.S. have PTSD each year and that around 13 million Americans had PTSD in 2020.
Mercer called it a “moral imperative” to help those suffering get access to the drug, a sentiment Correa echoed.
“We just don’t say we know it’s a game changer. We know it’s a game changer,” Correa said.
Despite the setback, Bergman said he is “confident that this will merely be a speed bump in our overall efforts to truly heal the invisible wounds that millions of Americans suffer from today.”