Congress rarely agrees on anything, but one issue they recently seemed to align on is MDMA.
Eighty members of Congress wrote letters to President Joe Biden, FDA Commissioner Robert Califf, and other top government officials on August 5 urging them to approve an MDMA therapy from Lykos Therapeutics.
The FDA is set to decide whether or not to approve the therapy, which is designed to treat post-traumatic stress disorder (PTSD), by August 11. If approved, it would be the first FDA-authorized psychedelic therapy, as well as the first new PTSD treatment in more than two decades. The last FDA-approved treatment was Paxil, a selective serotonin reuptake inhibitor (SSRI) that the FDA approved to treat PTSD in 2000.
“We write today to express our sense of urgency to address the PTSD and suicide epidemic among Veterans and servicemembers, and the grave need for new and better treatment options like MDMA-assisted therapy,” 61 representatives wrote in a letter addressed to Biden. Rep. Jack Bergman of Michigan, a retired Marine Corps Lt. General, led the House letter.
The letters from the House and Senate both underscored the importance of FDA approval for a new PTSD treatment, noting that existing treatments (SSRIs Paxil and Zoloft) haven’t been effective in decreasing the number of annual veteran suicides (6,000 per year, according to the Senate letter).
Roughly 5% of all US adults have PTSD, according to data from the Department of Veterans Affairs. And PTSD also has huge economic consequences, costing the US an estimated $232 billion in 2018, taking into account the costs of medical care, research, and indirect costs like unemployment and reduced productivity, according to a 2022 study.
Lykos’s MDMA therapy is “one of the most promising and available options” to treat PTSD, the senators wrote in their letter.
Patients receiving the therapy would get a capsule containing the MDMA drug, and be guided by therapists through three eight-hour long sessions spaced three to five weeks apart, as well as 12 drug-free therapy sessions. In a Phase 3 trial, 71% of patients no longer had symptoms meeting PTSD criteria after receiving Lykos’ MDMA therapy.
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Yes, but…The likelihood of MDMA therapy gaining approval is murky, as an FDA advisory committee in June voted 9–2 against recommending approval, citing a lack of evidence to prove the therapy is safe and effective. While the FDA typically sides with advisory committees, the agency has final say.
Following the advisory committee’s vote, Amy Emerson, CEO of Lykos Therapeutics, told Healthcare Brew the company will take the committee’s concerns into consideration and continue working alongside the FDA.
And in a move that could potentially ease some of the agency’s concerns, Lykos announced on August 1 steps it plans to take to boost oversight of the MDMA therapy if it receives approval, including forming an independent advisory board consisting of external experts from a variety of fields that will help Lykos plan a potential commercial launch.
Lykos already named three potential members of the oversight board: Barbara Rothbaum, a psychiatry professor at Emory University School of Medicine; Loree Sutton, a retired brigadier general who served as the highest-ranking psychiatrist in the Army; and former assistant US Attorney Robert Chesnut.
The company also plans to work with behavioral health facilities to make sure they’re prepared to properly dose patients with the MDMA therapy, noting that the drug would only be commercially available at facilities that meet FDA and Drug Enforcement Administration requirements.
In their letter, representatives acknowledged criticisms of the MDMA drug, writing: “It is our understanding that while these critics may be well-intentioned, their criticism is not necessarily reflective of the science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA.”
“While all Americans are free to voice their views on this and other topics of public interest, scientific evidence should not be ignored in favor of those who have been on a mission to discredit this promising treatment at all costs—especially when that would come at the cost of our servicemembers and Veterans,” the letter concluded.