Two veteran advocacy organisations, Reason for Hope and the Veteran Mental Health Leadership Coalition, have issued a joint statement urging the US Food and Drug Administration (FDA) to approve MDMA-assisted therapy for post-traumatic stress disorder (PTSD).

Last month, an FDA Advisory Committee recommended against approval, with only two out of 11 committee members voting that the evidence was sufficient to show efficacy; and one out of 11 voting that the benefits of MDMA alongside FDA’s proposed risked evaluation and mitigations strategy (REMS) outweighed the risk.

Data from a Phase III study in 2023 suggested that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated.

Co-founder of Reason for Hope and Founder & President of the Veteran Mental Health Leadership Coalition, Lieutenant General Martin Steele, US Marine Corps (Retired), said: “While we are bracing for a potential delayed decision, such a delay will only lead to more unnecessary suffering and lives lost. We have an urgent need for new PTSD treatments, and MDMA-AT has demonstrated safety and profound efficacy in clinical trials based on protocols negotiated and agreed upon with the FDA as part of a Special Protocol Assessment.”

“We hope the FDA will remain flexible to update its restrictions on safe use as additional safety data is collected, and that the government will invest in research for more effective care delivery models, therapist training, and the infrastructure needed to safely and equitably expand access to treatment. We are confident that if MDMA-AT can be made sufficiently accessible, it will prove to be amongst the most invaluable treatments ever developed to combat the veteran suicide epidemic.”

Diana Spencer, Senior Digital Content Editor, DDW