The U.S. FDA has declined to approve MDMA-assisted therapy for patients with post-traumatic stress disorder, citing that it could not be approved based on data submitted to them.

These elected officials (along with over 730 veterans from all 50 states as well as 14 VSOs) have signed onto letters agreeing that the FDA needs to seriously examine and consider the science demonstrating the effectiveness and long term potential of this breakthrough treatment for PTSD.

Juliana Mercer, a U.S. Marine Corps veteran and advocate, talks about the transformative effects of psychedelic-assisted therapy.

Healing Breakthrough’s Juliana Mercer , Director of Veteran Advocacy at Healing Breakthrough, joins the show to discuss how MDMA-assisted therapy is helping veterans diagnosed with PTSD and the push for FDA approval for this treatment.

Veterans & lawmakers gather together on the hill to urge the FDA to approve MDMA-AT for the thousands of veterans suffering from PTSD.

Message on the ICER report

Over the past year and a half, MDMA-AT’s efficacy has garnered a slew of positive press, FDA “Breakthrough Therapy” designation and fast-tracked approval consideration, bipartisan support from policymakers, and government funding through both the Department of Defense and the Department of Veterans Affairs. But earlier this spring, something changed in the media narrative.

Our friends at Heroic Hearts Project wrote up an informative piece on the current challenges facing the narrative surrounding MDMA-AT.

Bipartisan Congressional leaders passed two amendments supporting MDMA-AT adoption at the VA in the midst of National PTSD Awareness Month.

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

U.S. Department of Veterans Affairs (VA) Under Secretary of Health, Dr. Shereef Elnahal, spoke with Executive Director of Healing Breakthrough Executive Director, Dr. Jason Pyle, onstage at the Horizons conference in New York

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.

https://news.va.gov/press-room/to-improve-care-for-veterans-va-to-fund-studies-on-new-therapies-for-treating-mental-health-conditions/

https://news.va.gov/press-room/to-improve-care-for-veterans-va-to-fund-studies-on-new-therapies-for-treating-mental-health-conditions/

At least four times as many active duty personnel and war veterans of post-9/11 conflicts have died of suicide than in combat. Researchers at the VA have found that 17 Veterans a day lose their life to suicide with suicide being the second leading cause of death among Veterans under the age of 45.

At least four times as many active duty personnel and war veterans of post-9/11 conflicts have died of suicide than in combat. Researchers at the VA have found that 17 Veterans a day lose their life to suicide with suicide being the second leading cause of death among Veterans under the age of 45.

In June 2023, the FDA issued its first draft guidance on clinical trials with psychedelic drugs. The 14-page document presents non-binding guidance, or recommendations, regarding study design and other considerations for drug development programs investigating the therapeutic potential of…

In Phase II studies, researchers administer the drug to a group of patients with a disease or condition. A Phase III clinical trial tests the safety and how well a new treatment works compared with a standard treatment.