The Food and Drug Administration (FDA) recently dealt a significant blow to the emerging field of psychedelic medicine by declining to approve MDMA-assisted therapy for treating post-traumatic stress disorder (PTSD). This decision has disappointed many Americans seeking new treatments and is expected to set back the approval process by years, requiring an additional clinical trial that could cost millions of dollars.
MDMA, commonly known as Ecstasy or molly, was on the brink of becoming the first psychedelic compound regulated by federal health authorities. However, the FDA cited insufficient data to support its approval and asked Lykos Therapeutics, the company seeking approval, to conduct further research to determine whether the drug is safe and effective.
The FDA’s decision came after a group of independent experts, convened by the agency in June, did not recommend the treatment. The panel overwhelmingly concluded that Lykos had not sufficiently proven the treatment’s effectiveness, and that the benefits did not outweigh the risks. The FDA typically follows the recommendations of such panels, although critics have pointed out that only one of the 11 panel members had experience in psychedelic medicine.
Lykos Therapeutics expressed deep disappointment with the FDA’s request for another study, particularly given the high stakes for the millions of Americans suffering from PTSD who have had few new treatment options in the past two decades. Amy Emerson, Lykos’s chief executive, highlighted the setback in a statement, emphasizing the frustration and challenges that the decision presents for both the company and patients.
The FDA did not release the letter sent to Lykos outlining its decision but acknowledged the need for additional treatment options for mental health conditions like PTSD. The agency stated that it remains committed to encouraging research and drug development in psychedelic treatments and other therapies.
Despite the setback, supporters of psychedelic medicine, like Michael Pollan, remain optimistic about the future of the field. Pollan, a best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics, noted that while the FDA’s decision is a major challenge, it does not mark the end of progress in psychedelic medicine. The field has grown rapidly over the past decade, and there is still significant evidence and momentum to continue advancing psychedelic treatments.
MDMA was previously granted “breakthrough therapy” status by the FDA in 2017, a designation that recognizes a new drug’s potential benefits and accelerates the review process. MDMA, or midomafetamine, promotes self-reflection and feelings of connectedness, and was widely used by psychotherapists before it was banned in 1985. Lykos worked closely with the FDA to design the clinical trials used to evaluate MDMA-assisted therapy’s safety and efficacy.
The company’s published results were promising, with more than two-thirds of patients who received MDMA no longer qualifying for a PTSD diagnosis six months after their final treatment. However, Lykos’s application was unconventional due to the illegal status of MDMA and the inclusion of talk therapy, which the FDA does not regulate. The agency’s request for additional trials appeared to stem from concerns about potential biases in the data, particularly the inclusion of patients who had previously tried MDMA.
Military veterans, who suffer from disproportionately high rates of PTSD, were particularly hopeful for this new treatment. Lt. General Martin R. Steele, co-founder of Reason for Hope, expressed frustration with the FDA’s decision, citing the urgent need for more effective PTSD treatments.
The FDA’s decision has raised concerns about the impact on other psychedelic drugs under review, including LSD for generalized anxiety disorder and psilocybin for severe depression. Still, many in the field, including Dr. Manish Agrawal of Sunstone Therapies, believe that the decision, while disappointing, will not halt progress in psychedelic medicine. He suggests that future studies may need to focus more on the psychotherapeutic component of treatments.
Supporters of psychedelic medicine, like Taylor West of the Healing Advocacy Fund in Oregon, are considering alternative paths to bring these treatments to market, including focusing on state-level initiatives. States like Oregon and Colorado, which have recently legalized psilocybin treatments, may offer a more viable route for advancing psychedelic-assisted therapy.
 recently dealt a significant blow to the emerging field of psychedelic medicine by declining to approve MDMA-assisted therapy for treating post-traumatic stress disorder (PTSD). This decision has disappointed many Americans seeking new treatments and is expected to set back the approval process by years, requiring an additional clinical trial that could cost millions of dollars.){kind=link}