The Food and Drug Administration announced its decision on midomafetamine-assisted therapy, commonly called MDMA-AT, late Friday afternoon. The FDA chose not to approve the drug for helping treat post-traumatic stress disorder. The announcement caused an uproar throughout the veteran community. Non-profit groups Heroic Hearts Project and Healing Breakthrough released a direct response soon after the FDA announced their decision.
“This is the epitome of bureaucratic red tape – and the result is people will keep dying. MDMA-AT is the most effective treatment ever developed for PTSD, a condition at the core of the Veteran suicide crisis that claims over 17 lives each day,” their joint statement said.
MDMA is a psychoactive drug and is the main active ingredient in illegal drugs like ecstasy, though law enforcement often finds a mix of other illegal drugs laced into the illicit street drug. However, many trauma specialists and a wide community of veterans believe MDMA can alleviate mental conditions that often afflict veterans, such as PTSD and depression.
The FDA’s decision came after an FDA Advisory Committee voted against the drug’s approval in early June. The FDA didn’t officially say no to the bid but requested an additional Phase 3 trial, echoing the advisory committee’s comments about the efficacy of the research presented to the FDA. They claimed the studies were flawed and could have skewed results, along with concerns over missing follow-up data on patient outcomes and a lack of diversity in the trial group.
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61 members of the House of Representatives and 19 Senators sent two bipartisan letters to President Joe Biden on Aug. 5, urging for FDA Approval to “follow the science” of MDMA-AT to be implemented to treat post-traumatic stress disorder.
Those two letters were accompanied by another letter from Healing Breakthrough, penned by over 700 veterans and 14 veteran service officers with a similar message.
Though the FDA denied it, they are requesting another Stage 3 trial to be completed before they would reevaluate their findings. Healing Breakthrough and the Heroic Hearts Project joint statement struck back at the delay in approving MDMA-AT.
“The FDA’s decision is a missed opportunity to embrace groundbreaking science, save countless Veteran lives, and honor the sacrifices made by those who served our country,” the statement continued. “If this critical treatment remains inaccessible, we face losing an additional 6,000 Veterans to suicide this year alone — and every year thereafter.”
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