Already a subscriber? Make sure to log into your account before viewing this content. You can access your account by hitting the “login” button on the top right corner. Still unable to see the content after signing in? Make sure your card on file is up-to-date.
The Food and Drug Administration (FDA) has shot down a potential treatment for post-traumatic stress disorder using the psychedelic MDMA.
On Tuesday, a panel of federal regulators overwhelmingly rejected the treatment, voting 10-1 against endorsing MDMA’s safety for PTSD and 9-2 against its efficacy. The panel pointed to flawed studies, unclear data, and potential for harmful side effects as primary concerns. Although the FDA is not bound by the panel’s recommendation, the extensive criticism provides substantial grounds for rejecting the treatment.
This meeting marked the first time the FDA considered the use of a Schedule 1 psychedelic drug for medical purposes. Lykos Therapeutics, the company behind the treatment and backed by the Multidisciplinary Association for Psychedelic Studies, expressed disappointment but vowed to work with the FDA for future approval. In a statement, the company’s CEO said, “We are disappointed in today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention.”
The panel raised specific concerns regarding the diversity of study subjects and the replicability of results. They also noted the difficulty in maintaining a placebo control due to the noticeable effects of MDMA, which does not cause hallucinations but alters emotions. Panel member Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs, highlighted the numerous issues with the data, stating, “It seems like there are so many problems with the data — each one alone might be OK, but when you pile them on top of each other … there’s just a lot of questions I would have about how effective the treatment is.”
Critics of the decision, including the advocacy group Healing Breakthroughs, argued that the panel overlooked the urgent need for effective PTSD treatments. Juliana Mercer, the group’s veteran advocacy director, emphasized the ongoing veteran suicide crisis, stating, “Six thousand veterans have died from suicide every single year since 9/11… This is a gut-wrenching statistic that has remained unchanged, despite billions of taxpayer dollars and myriad treatments that have proven ineffective in bringing the veteran suicide epidemic to an end.”
