Home » Veteran Advocates Disappointed as FDA Panel Rejects MDMA-Based PTSD Treatment

Veteran Advocates Disappointed as FDA Panel Rejects MDMA-Based PTSD Treatment

by Richard A Reagan

A U.S. Food and Drug Administration (FDA) panel has rejected MDMA-based treatments for post-traumatic stress disorder (PTSD), disappointing many veterans and mental health advocates. 

On June 4, the advisory committee voted 10-1 against the overall benefits of MDMA for treating PTSD, citing concerns about study flaws, unclear data, and potentially damaging side effects. 

The nine-hour-long hearing, held in Silver Spring, Maryland, led to a further 9-2 vote against the drug’s efficacy.

The drug application for psychedelic-assisted therapies was filed by Lykos Therapeutics in California earlier this year. In a statement on June 4, the company expressed disappointment in the FDA’s decision.

“We are disappointed in today’s vote, given the urgent unmet need in PTSD, and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Lykos Therapeutics CEO Amy Emerson. 

“We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the health care system, if approved,” Emerson added.

Juliana Mercer, a 16-year Marine Corps veteran and director of the nonprofit Healing Breakthrough based in San Diego, has been a leading advocate of psychedelic-assisted therapies in treating mental health challenges.

In an interview with Fox News Digital, Mercer described the verdict as a “big gut punch.”

“When I heard the verdict, all I could think about was the hopes of those veterans being dashed … and not having a solution for them,” Mercer said. 

She noted that many large veteran organizations and individual veterans who had undergone the therapy testified about the life-saving treatment they received. 

One Marine veteran spoke to the panel about phone calls from veterans asking, “How do I get this treatment?” Mercer shared similar experiences, stating, “Veterans have heard that this works. They’ve seen the data and the science, and they’ve been desperately waiting for this approval.”

Despite the setback, Mercer is hopeful that the decision will be overruled. “We haven’t had a new PTSD drug for over 20 years. And the ones that we have are not as effective as we need them to be,” she said, highlighting the urgent need for effective treatments.

The FDA emphasized that the review of the drug application is ongoing. 

“The FDA appreciates the input from the Psychopharmacologic Drugs Advisory Committee,” an FDA spokesperson wrote in an email to Fox News Digital. “Following the meeting, FDA career staff will take the committee’s input into account as they continue their review of the new drug application.”

The Department of Veteran Affairs (VA) currently has 13 MDMA-based trials underway.

VA Press Secretary Terrence Hayes noted that while the agency closely monitors the FDA’s decisions, it cannot comment on the recommendations of the FDA advisory committee or the FDA’s pending decision on the new drug application.

“VA is committed to high-quality research that safely promotes the health of our nation’s veterans,” Hayes stated.

The VA plans to conduct additional studies under stringent protocols to evaluate if psychotherapy in combination with compounds such as MDMA and psilocybin are effective for treating veterans with PTSD and other mental health conditions.

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, interviewed two of the country’s top researchers on psychedelics earlier this year. 

Dr. Rachel Yehuda, founder and director of the Center for Psychedelic Psychotherapy and Trauma Research at Mt. Sinai in New York, and Dr. Charles Marmar, director of the PTSD research program at NYU Langone, have been at the forefront of studying these innovative treatments.

As the FDA continues its review, the veteran community and mental health advocates remain hopeful that MDMA-assisted therapies will eventually gain approval.

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