The Food and Drug Administration (FDA) has rejected the approval of MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder (PTSD).
This decision has disappointed military veterans and lawmakers who have been advocating for new treatment options for the disorder.
Lykos Therapeutics, a California-based company, had sought approval to market MDMA in combination with talk therapy as a groundbreaking treatment for PTSD.
The FDA’s rejection comes after a comprehensive review of the application, with the agency citing the need for an additional advanced-stage clinical study to further assess the drug’s safety and effectiveness.
This decision has been met with deep disappointment, particularly among those who have long advocated for innovative solutions to the persistent mental health challenges faced by many veterans.
Amy Emerson, CEO of Lykos Therapeutics, expressed her frustration, stating, “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades.”
The rejection comes after the FDA’s Psychopharmacologic Drugs Advisory Committee voted overwhelmingly against the approval of MDMA for PTSD treatment.
Concerns raised by the committee centered on the quality of the research conducted by Lykos, with some members questioning the design and data of the studies presented. However, Lykos Therapeutics remains optimistic that the issues identified can be addressed through existing data and further discussion with the FDA.
Earlier studies had shown promising results, with approximately 86% of participants who received MDMA treatment along with therapy reporting reduced PTSD symptoms.
Notably, 71% of these participants no longer met the diagnostic criteria for PTSD after the treatment. In contrast, only 48% of those in the placebo group showed similar improvements.
Support for the treatment extended to Capitol Hill, where a bipartisan group of 60 House members, led by U.S. Rep. Jack Bergman (R-MI), sent a letter to President Joe Biden urging a fair review of the therapy.
The letter highlighted the FDA’s failure to approve any new PTSD treatments in 25 years, a stagnation that some believe has contributed to rising suicide rates among veterans.
As Lykos Therapeutics prepares to meet with the FDA to discuss a possible reconsideration of the decision, the rejection of MDMA as a PTSD treatment serves as a reminder of the ongoing challenges in addressing the mental health crisis affecting America’s veterans.
Critics argue that the lack of innovation and support for new treatments is symptomatic of broader issues within the current administration’s approach to healthcare, leaving many veterans without the help they desperately need.