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A U.S. Food and Drug Administration (FDA) panel rejected MDMA-based treatments for post-traumatic stress disorder (PTSD) that are often used in veteran care.
On June 4, the advisory committee voted 10-1 against the overall benefits of MDMA when used to treat PTSD, according to the Associated Press.
MARINE VET TOUTS BENEFITS OF PSYCHEDELIC-ASSISTED PTSD DRUGS AS FDA CONSIDERS MDMA APPROVAL
During the nine-hour-long hearing — which was held in Silver Spring, Maryland — the panel addressed some concerns about study flaws, unclear data and potentially damaging side effects, leading to another 9-2 vote against drug efficacy.
The drug application for psychedelic-assisted therapies was filed by Lykos Therapeutics in California earlier this year.Â
“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,” one advocate said. (iStock)
The company expressed its disappointment in the FDA’s decision in a statement on June 4.
“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.Â
“We are disappointed in today’s vote, given the urgent unmet need.”
“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.”
In a statement sent to Fox News Digital, the FDA echoed the intent for an ongoing review of the drug application.
“The FDA appreciates the input from the Psychopharmacologic Drugs Advisory Committee,” an FDA spokesperson wrote in an email. “Following the meeting, FDA career staff will take the committee’s input into account as they continue their review of the new drug application.”
An FDA panel has rejected MDMA-based treatments for post-traumatic stress disorder (PTSD) that are often used in veteran care. (iStock)
Juliana Mercer, a 16-year Marine Corps veteran and director of the nonprofit Healing Breakthrough, who is 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 said the verdict felt like a “big gut punch.”
She added, “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.”
At the hearing, Mercer said there were “quite a few large veteran organizations that shared the great need for a solution to PTSD.”Â
“There were also individual veterans who had undergone the therapy and talked about this life-saving treatment they received,” she added.
U.S. Marine Juliana Mercer is pictured deployed in Helmand Province, Afghanistan, in 2010. The now-veteran also battled PTSD. (Juliana Mercer)
One Marine veteran spoke to the panel about the phone calls he has received from veterans asking, “How do I get this treatment?”
“I get those same calls,” Mercer said. “Veterans have heard that this works. They’ve seen the data and the science, and they’ve been desperately waiting for this approval.”
Following the decision, Mercer said, “I just had a pit in my stomach, thinking about those veterans … who shared their testimony. It took me about 48 hours to go from basically grief to recognizing that we had an uphill battle, and I was ready to do everything it took to win this fight.”
Juliana Mercer, pictured, testified on Capitol Hill in November 2023 to advocate for psychedelic-assisted therapies in front of he House Committee for Veterans’ Affairs. (Juliana Mercer)
Mercer noted that the conversation with the advisory committee veered from data and facts into a “conversation about drug abuse, integrity and motivation.”
“They were saying there was not enough data and facts to approve it, basically,” she said. “This is the first time we’ve had something that actually has science and data behind it to actually heal or eliminate a PTSD diagnosis — and they refuse to look at that.”
KETAMINE THERAPY SHOWN EFFECTIVE IN TREATING SEVERE DEPRESSION IN VETERANS, STUDY FINDS
Mercer said she is “holding out hope” that this 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.”Â
“There is a huge downside in terms of unregulated recreational uses.”
