MDMA-Assisted Therapy Advances Towards FDA Approval

Healing Breakthrough celebrates the FDA’s latest announcement on MDMA-AT, bringing the promising therapy one step closer to healing Veterans who suffer from PTSD.

February 12, 2024 (Washington, D.C.) - Healing Breakthrough, the leading federal advocacy group for Veteran access to MDMA-assisted therapy (MDMA-AT), celebrates the U.S. Food and Drug Administration’s (FDA) acceptance of a new drug application (NDA) for midomafetamine (MDMA) capsules used in combination with talk therapy for those who suffer from Post-traumatic stress disorder (PTSD). The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024 to make the review determination.

MDMA-AT offers real hope to Veterans who suffer from PTSD; a primary contributor to the suicide epidemic that has claimed over 100,000 veteran lives since 9/11. MDMA-AT’s Phase three clinical trials found that 71% of trial participants no longer qualified for a PTSD diagnosis after three eight-hour MDMA-AT therapy sessions, while 87% experienced clinically significant improvement in their symptoms. 

Healing Breakthrough recognizes that MDMA-AT offers the greatest promise for a near-term solution to bringing the Veteran suicide epidemic to an end. Thus, in addition to its advocacy in Washington, D.C., the organization has also designed, developed, and facilitated five of the eight privately-funded MDMA-AT research studies at the VA, and funded two of the five studies directly. Healing Breakthrough also granted the VA’s National Center for Post-Traumatic Stress Disorder (NCPTSD) funding last year to assess the feasibility and safety of MDMA-AT in a first-of-its-kind clinical research study, which is led by the Executive Director of the NCPTSD, Dr. Paula Schnurr.

“We’re grateful to those in Washington, D.C., who are working overtime to pave the way for MDMA-AT’s acceptance and approval,” said sixteen-year Marine Corps veteran Juliana Mercer, who serves as Healing Breakthrough’s Director of Veteran Advocacy and Public Policy. “From MDMA-AT’s designation in 2017 as an FDA ‘Breakthrough Therapy,’ to the VA’s recent decision to fund MDMA-AT studies on Veteran-specific populations, the federal government is putting skin in the game after decades of philanthropically-funded private research. Healing Breakthrough will continue supporting the VA’s efforts, while pressing forward with our primary advocacy goal: ensuring that Veterans are able to access MDMA-AT’s healing potential, both safely and legally through the VA’s healthcare system.” 

For more information on Healing Breakthrough, please visit our main site https://www.healingbreakthrough.org/.