Healing Breakthrough’s Statement on the FDA Advisory Committee’s Decision Regarding MDMA-Assisted Therapy
June 4, 2024 (Washington, D.C.) - Today’s decision by the FDA Advisory Committee to advise against approving MDMA-Assisted Therapy (MDMA-AT) as a treatment for PTSD elicited deep disappointment among the million veterans who suffer disproportionately from PTSD. Despite supportive testimony from leading veteran advocacy organizations (including Wounded Warrior Project, Disabled American Veterans, and Veterans of Foreign War), the former head of psychiatry for the armed services (Brig. Gen. Loree Sutton), and personal testimonies of healing from brave service members, a majority of Advisory Committee members failed to support the FDA’s proposal to approve MDMA-AT.
“With all due respect to the Committee, they’ve missed the forest for the trees. 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,” said Juliana Mercer, Director of Veteran Advocacy and Public Policy for Healing Breakthrough.
Published results from Lykos’ Phase 3 clinical trials showed a 71% efficacy rate in eliminating PTSD diagnoses, making MDMA-AT the most promising treatment for PTSD currently administered or presently being studied and the first new treatment for PTSD in over 20 years. Hundreds of patients have experienced significantly reduced symptoms of PTSD, or loss of their PTSD diagnosis, as a result of their treatment in clinical studies. Consequently, veteran-led advocacy has resulted in MDMA-AT earning the support of leading VSOs and bipartisan members of Congress. The VA’s leadership has also expressed its strong support for MDMA-AT, as evidenced by its recently issued funding announcement for VA-administered clinical trials of this FDA designated “Breakthrough Therapy.”
Delaying FDA approval of MDMA-AT dashes the hopes of millions of Americans who suffer from PTSD. It also means that more veteran lives will be unnecessarily lost to suicide this year, and every year, until this therapy is approved. We are deeply disappointed in the Advisory Committee’s decision today, particularly given that it was issued at the start of National PTSD Awareness month. However, we are more committed than ever to working with the FDA, VA, and members of Congress to ensure that our veterans get access to this life-saving treatment, which offers the greatest hope for bringing our veteran suicide epidemic to an end.”
For more information on Healing Breakthrough, please visit our main site https://www.healingbreakthrough.org/.