Marine vet touts benefits of psychedelic-assisted PTSD drugs as FDA considers MDMA approval

 PTSD sufferers may soon get a new path to relief.

A drug application for psychedelic-assisted therapy has been filed by Lycos Therapeutics, formerly MAPS PBC, for FDA approval.

The U.S. Food and Drug Administration (FDA) had 60 days until December 12, 2023, to respond to its long-awaited decision, according to a January 10 news release from California-based Lycos.

If approved, the U.S. Drug Enforcement Administration (DEA) would have to reclassify (reclassify) MDMA – also known as Ecstasy – to make it legal for prescription therapeutic use.

The Department of Veterans Affairs (VA) also announced on January 5 that it had commissioned the VA to study the use of psychedelic compounds, including MDMA and psilocybin (magic mushrooms), when used in combination with psychotherapy to treat PTSD and depression. Proposals have been issued for researchers.

The VA confirmed in an email to Fox News Digital that the research would be the first of its kind since the 1960s.

While some people are hesitant, Julianna Mercer, a 16-year Marine Corps veteran, has been a leading advocate of psychedelic-assisted therapies in the treatment of mental health challenges.

Mercer, who lives in San Diego, is the director of veteran advocacy and public policy at Healing Breakthrough, an organization that aims to drive adoption of MDMA-assisted therapy into the VA system.

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In an interview with Fox News Digital, the veteran said that MDMA therapy has been shown to be 71% effective in eliminating PTSD in two Phase 3 clinical trials.

Mercer expects the FDA to hold a hearing on its decision "very soon" — and he said he's hopeful the agency will give the drug the green light.

"We are quite confident and optimistic that it will be approved," he said. “And once that happens, there is some more paperwork that needs to be done in hopes of having MDMA prescribed by health care providers in mid to late 2024.”

When contacted for comment, the FDA told Fox News Digital it could not discuss the existence or status of any pending applications.

Mercer, who spent deployments in Iraq and Afghanistan, struggled with PTSD until she "fell out" in 2019, she said.

The veteran sought talk therapy, which helped him "not feel so alone," he said — but it didn't help him "deal with the problem."

After being introduced to the Heroic Hearts Project, a Florida non-profit organization, Mercer came to the U.S. Became able to access psychedelic therapy outside of the U.S.

“After treatment that lasted almost overnight, in combination with the talk therapy I was doing and with a psychedelic coach, I was able to get to the root cause, and regain my happiness and my love. And went back to work with the veterans community," she told Fox News Digital.

Mercer said her experience became a "catalyst" for advocating for medical access, as she recently testified during a Nov. 14 hearing on Capitol Hill.

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He addressed the House Committee on Veterans Affairs regarding the efficacy of these treatments, claiming that the trial results "cannot be overstated."

Mercer told Fox News Digital that she believes it is "such a huge injustice" that "nothing is working" for struggling vets in the US.

“I felt like I needed to shout it from the rooftops and find a way to make it available to my veteran brothers and sisters,” he said.
"The suicide epidemic is killing us at a rate greater than the death toll of 20 years of war," Mercer said. “We are losing more than 6,000 veterans per year to suicide.”

In a press release discussing the implementation of psychedelic research, VA Secretary Dennis McDonough wrote that America's veterans "deserve the best care, and VA is continually supporting innovations to provide it."

He added, "This is an important step forward in exploring the efficacy of a potential new set of promising treatments that could improve veterans' health and quality of life."

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Dr. Sherif Elnahal, VA's undersecretary for health, commented in the same release that veterans and VA researchers have been vocal about "the potential promise of psychedelics to treat mental health conditions for some time."

"We now have the opportunity to study this potential method of treating veterans suffering from PTSD and major depression across the country," they wrote.

Mercer elaborated that MDMA therapy is the first of these novel treatments to be considered for FDA approval, claiming that two-thirds of patients no longer qualify for a PTSD diagnosis after treatment.

Another psychedelic option is psilocybin, also known as “magic mushrooms.”

It has also shown promising results when it enters Phase 3 clinical trials.

Since approval of psilocybin-assisted treatments "may take a few years", Mercer said the potential approval of MDMA is "the tip of the spear" when it comes to saving veterans' lives.

According to Mercer, the MDMA drug is administered orally during approximately eight-hour sessions inside the clinic, with guidance from a mental health care provider.

The patient undergoes talk therapy for a month before receiving the medication – and then for another month after that.

Mercer reported that the VA is considering expanding talk therapy options beyond one-on-one sessions to include group conversations and sessions with significant others.

Dr. Yuval Neria, director of the PTSD Research and Treatment Program at Columbia University in New York, shared his optimism about this mode of therapy with Fox News Digital.

"Veterans with PTSD suffer from a number of interpersonal problems, including PTSD, depression, severe difficulties in relationships with their partners, functional impairment, and suicide," he said. "Yet there is a severe lack of effective treatments, especially in VA settings."

Some PTSD treatments that are considered the "gold standard" require veterans to "let go of their traumas," which "is not optimal among many people," Neria said.

"As a result, attrition rates from traditional talk therapy are very high (36% to 68% depending on the method)," he said.

The FDA's potential approval of a treatment involving MDMA represents a "promising step," Neria said.

"Many veterans seek a greater 'transparent' experience to combat their trauma experience," he said. “They want to press the ‘reset’ button, and hope that psychedelics will do that rapidly, with little effort on the part of the experiencer.”

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