MDMA therapy is getting closer to approval | ET REALITY

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MDMA-assisted therapy appears to be effective in reduce symptoms of post-traumatic stress disorderaccording to a study published Thursday.

The research is the final trial conducted by MAPS Public Benefit Corporation, a company that develops prescription psychedelics. It plans to submit the results to the Food and Drug Administration as part of an application for approval to market the psychedelic drug MDMA as a treatment for post-traumatic stress disorder, when combined with psychotherapy.

If approved, “MDMA-assisted therapy would be the first novel treatment for post-traumatic stress disorder in more than two decades,” said Berra Yazar-Klosinski, lead author of the study, which was published in Nature Medicine, and scientific director of the company. . “PTSD patients may feel some hope.”

PTSD affects approximately 5 percent of the United States adult population each year. But conventional therapies and medications only help, at best, about 50 percent of patients, said Dr. Stephen Xenakis, a psychiatrist and executive director of the American Association of Psychedelic Practitioners, who was not involved in the study. the study.

“My clinical experience is that too many men and women have lost hope with conventional treatments and therapies and feel that the only ‘way out’ for them is suicide,” said Dr. Xenakis. “We need to do more to help them, and MDMA-assisted therapy offers a new option that can save lives when done carefully and professionally.”

MDMA, also known as Ecstasy or Molly, has been an illegal substance since 1985, when the Drug Enforcement Administration classified it as a Schedule 1 drug, placing it in the highest category of controlled drugs that the agency considers to have no medical use and that have a high potential for abuse.

Before that, it is estimated that hundreds of therapists in North America and Europe administered MDMA for couples therapy, personal growth, and trauma treatment.

“The big tragedy to note is that in the late 1970s and early 1980s it was pretty clear that MDMA had incredible therapeutic potential,” said Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS). a nonprofit group that owns MAPS. PBC. “All the suffering since then, because MDMA was criminalized, is enormous.”

MAPS has been advocating for the legalization of MDMA-assisted therapy since 1986 and supporting research into its use in the treatment of post-traumatic stress disorder since 2001. The Heffter Research Institute, another nonprofit group, has been doing the same. Same with psilocybin, the active ingredient in magic mushrooms. From 1993.

In 2017, the FDA granted “breakthrough therapy” status to MDMA-assisted therapy as a treatment for post-traumatic stress disorder. The designation allows the development of promising experimental drugs to be accelerated. Psilocybin-assisted therapy for treatment-resistant depression achieved breakthrough status in 2018.

The 104 participants in the new study had been diagnosed with moderate to severe post-traumatic stress disorder and had lived with the condition for an average of 16 years. They included victims of childhood trauma, combat veterans, survivors of sexual assault and others. Many had a history of suicidal thoughts and also suffered from comorbidities such as depression and alcohol use disorder.

Each participant worked with a two-person therapy team and received three 90-minute preparatory psychotherapy sessions followed by three treatment cycles, one month apart. Each consisted of an eight-hour experimental session in which the participant took MDMA or a placebo combined with talk therapy, and then attended three 90-minute talk therapy sessions.

During the experimental sessions, 53 participants received MDMA and 51 an inactive placebo. Neither therapists nor participants were informed which patients had received MDMA.

According to the research article, participants in the group that received MDMA experienced significantly greater reductions in their PTSD symptoms compared to those in the group that received a placebo.

At the end of the study, 86.5 percent of people in the MDMA group achieved a measurable reduction in symptom severity, the researchers reported. About 71 percent in the MDMA group improved enough to no longer meet the criteria for a PTSD diagnosis. Of those who took the placebo, 69 percent improved and nearly 48 percent no longer qualified for a PTSD diagnosis.

The findings were similar to the results of first phase 3 study of MDMA-assisted therapy for post-traumatic stress disorder, published in Nature Medicine in 2021. For the 90 participants in that study, 67 percent in the group that received MDMA no longer qualified for a diagnosis of post-traumatic stress disorder two months after treatment, compared with 32 percent in the placebo group. .

One notable difference in the most recent study was the diversity of participants, said Jennifer Mitchell, a neuroscientist at the University of California, San Francisco and lead author of both studies.

More than a quarter of participants in the new study were Hispanic or Latino and about 34 percent were nonwhite, while about 9 percent of participants in the 2021 study were Hispanic or Latino and 22 percent They were not white.

“We worked long and hard to get a study population that more closely matched the general PTSD population,” Dr. Mitchell said. “It’s not just about privileged people with lots of time and resources.”

The increase in participant diversity coincided with an increase in the number of therapists of color, to 28 percent in the new study, up from 11 percent in 2021. MAPS PBC said it also offered participants transportation to and from the study sites, as well as stipends to compensate for lost wages or to cover child or elder care.

The diversity of participants is “certainly an improvement over previous studies,” said Albert García-Romeu, a psychopharmacologist at the Johns Hopkins University School of Medicine who was not involved in the research. But he added that “it will be critical for more Black and Indigenous people to sign up, considering the significant health disparities these groups face.”

As in previous studies of MDMA-assisted therapy, the treatment was generally well tolerated, based on data presented on adverse events. Common side effects, primarily for those in the MDMA group, included muscle tension, nausea, decreased appetite, and sweating.

Two participants in the MDMA group and one in the placebo group experienced severe suicidal ideation during the study, but no suicide attempts were reported.

“People in both groups had certain adverse events that would be concerning, such as suicidality, at comparable rates, although it is notable that most people in the study were already struggling with those challenges beforehand,” Dr. García said. Romeu.

In total, seven participants also experienced cardiovascular problems, including faster heartbeats. According to Dr. Paul Summergrad, a professor of psychiatry at Tufts University School of Medicine, who was not involved in the research, while these events were “generally not serious,” they could indicate that patients should be evaluated by a cardiologist. older or those with known heart disease. problems before MDMA treatment.

MAPS PBC said it had worked closely with the FDA to determine the study methods and the number of participants needed to evaluate the safety and effectiveness of the new treatment.

Most participants correctly guessed whether they had received placebo or MDMA. This is a typical challenge in all psychiatric research and is something that “the authors recognized and did everything they could to mitigate,” said Dr. Steven Zalcman, chief of the Adult Pathophysiology and Biological Interventions Development Branch at the National Institutes of Health. of Mental Health, which was not involved in the investigation.

Researchers are now working on a follow-up study examining the long-term durability of the effects of MDMA-assisted therapy. Findings from the MAPS-sponsored Phase 2 studies indicated that the The benefits lasted at least 12 months. for the majority of participants who received the drug.

MAPS PBC plans to submit a new drug application to the FDA seeking approval for MDMA-assisted therapy. The agency, which does not comment on pending drug reviews, could reach a decision within a year.

Some outside experts said they did not believe the study results met the FDA’s approval criteria.

“The benefits in the active group were actually not much greater than the benefits in the placebo group,” said Dr. Allen Frances, professor emeritus of psychiatry at Duke University. “Treatment with MDMA would add enormous costs to the treatment system while providing only a small, specific benefit, and would therefore result in a massive misallocation of already very scarce resources.”

Dr. Akua Prieto Brown, medical director of Alchemy Community Therapy Center in Oakland, California, who was also not involved in the study, however criticized this “scarcity mentality” and said health professionals’ approach should instead Instead, it should focus on “increasing treatment options for a condition that is notoriously difficult to treat.”

Disagreements among mental health professionals are to be expected, Dr. Xenakis said, adding that “tectonic shifts of this dimension are disruptive and may produce more fractures among professionals than agreements.”

Federal approval for MDMA-assisted therapy would also mean that the drug would have to receive a less serious classification as a controlled substance by the DEA and the states.

Therapist training is another possible obstacle. The company already oversees its own therapist training program and is working with other partners, including universities, to increase training.

The specific standards and requirements the FDA might require of prescribers, and what the agency would outline for MDMA-assisted therapy labeling instructions, are still open questions, said Amy Emerson, executive director of MAPS PBC.

“Medication-assisted therapy hasn’t been approved before, so there isn’t much precedent,” he said.

The company has not yet set a price for the drug, Emerson said, and will not control how much the therapy component will cost.

But he is contacting insurance companies, Medicaid and Medicare to try to secure coverage, Emerson said. The group is also working on patient access programs to help those without coverage and unable to pay out of pocket to receive discounts or even free treatment.

Given the obstacles still ahead, “it seems too early to really celebrate,” Dr. Doblin said. “But it’s been a very, very long process, and it’s amazing that we’ve gotten this far.”

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