FDA denies MDMA-assisted therapy for treating PTSD

The Food and Drug Administration announced its decision on midomafetamine-assisted therapy, commonly called MDMA-AT, late Friday afternoon. The FDA decided not to approve the drug for the treatment of post-traumatic stress disorder. The announcement sparked an uproar throughout the veterans community. Nonprofit organizations Heroic Hearts Project and Healing Breakthrough released a direct response shortly after the FDA's decision was announced.

“The FDA's decision is a missed opportunity to capitalize on groundbreaking science, save countless veterans' lives, and honor the sacrifices of those who have served our country,” their joint statement said. “If this important treatment continues to be inaccessible, we will lose another 6,000 veterans to suicide this year alone – and every year after that.”

MDMA is a psychoactive drug and the main active ingredient in illegal drugs such as ecstasy, although police often find a mix of other illegal drugs in the illegal street drug. However, many trauma specialists and the wider veteran community believe that MDMA can alleviate mental illnesses that commonly plague veterans, such as PTSD and depression.

The FDA's decision came after an FDA advisory committee voted against approving the drug in early June. The FDA did not officially reject the offer but requested an additional Phase 3 trial, echoing the advisory committee's comments about the effectiveness of the research submitted to the FDA. They claimed the studies were flawed and may have skewed the results, and there were concerns about a lack of follow-up data on patient outcomes and a lack of diversity in the study group.

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Sixty-one members of the House of Representatives and 19 senators sent two bipartisan letters to President Joe Biden on August 5, urging the FDA to approve MDMA-AT to treat post-traumatic stress disorder “on a scientific basis.”

Attached to these two letters was another letter from Healing Breakthrough, written by over 700 veterans and 14 experienced officers, containing a similar message.

Although the FDA declined, it is demanding that another Phase 3 trial be conducted before it can re-evaluate its results. In a joint statement, Healing Breakthrough and the Heroic Hearts Project opposed the delay in approving MDMA-AT.

“The FDA's decision is a missed opportunity to capitalize on groundbreaking science, save countless veterans' lives, and honor the sacrifices of those who have served our country,” the statement continued. “If this important treatment continues to be inaccessible, we will lose another 6,000 veterans to suicide this year alone – and every year after that.”

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