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What Is MDMA Therapy for PTSD? And What Are Its Risks?

The Food and Drug Administration is considering whether to approve the use of MDMA, also known as ecstasy, for the treatment of post-traumatic stress disorder. An independent expert advisory group reviewed the studies on June 4 and decided not to approve the treatment.

Lykos Therapeutics submitted evidence from clinical trials in an effort to gain agency approval to legally sell the drug to treat people with a combination of MDMA and talk therapy.

Millions of Americans suffer from PTSD, including veterans who are at high risk of suicide. No new treatment for PTSD has been approved in more than 20 years.

Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a Bay Area psychedelic chemist, MDMA gained popularity among therapists. . Early research suggests significant therapeutic potential for a number of mental health conditions.

MDMA is an entactogen, or empathogen, which promotes self-awareness, feelings of empathy, and social bonding. It’s not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, MDMA is commonly known as molly or Ecstasy.

In 1985, as the drug became a staple of dance clubs and raves, the Drug Enforcement Administration classified MDMA as a Schedule I substance, a drug defined as having no accepted medical use and a high potential for ‘abuse.

FDA agency staff raised concerns about “significant increases” in blood pressure and pulse rate in some of the Lykos clinical trial participants, noting that these were risks that could “trigger cardiovascular events.

Many experts in the field claim that the drug is generally safe and not addictive in its pure form.

Adverse effects associated with MDMA when taken outside of a clinical setting are often caused by adulterants like methamphetamine and synthetic cathinones, often called bath salts.

Some recreational users report a drop in mood in the days after taking MDMA, likely due to a temporary lack of serotonin in the brain, but experts say more research is needed.

In 2017, the FDA granted “breakthrough” status to MDMA-assisted therapy. This status, recognition of the therapeutic promise of a drug, aims to shorten the regulatory deadline.

The original application was sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies, which earlier this year created a for-profit entity, Lykos Therapeutics, to market MDMA if it gained FDA approval.

The application presents an unusual challenge for the FDA, which generally does not regulate drug treatments associated with talk therapy — a key part of Lykos’ regimen to treat PTSD.

On June 4, an expert advisory committee reviewed Lykos’ clinical data, hearing from the public and agency staff, which had published an analysis in late May. The expert panel rejected the request, citing concerns about effectiveness and safety. The agency often follows the committee’s suggestions and a final decision is expected in mid-August.

About 200 patients in the Lykos clinical trials underwent three sessions of eight hours each, during which about half received MDMA and the other half a placebo, according to a report published in Nature Medicine. The sessions were spaced four weeks apart.

Patients also had three appointments to prepare for therapy and nine more in which they discussed what they had learned.

The most recent drug trial found that more than 86 percent of those who received MDMA achieved a measurable reduction in the severity of their symptoms. About 71 percent of participants improved enough to no longer meet the criteria for a PTSD diagnosis.

Any agency approval would likely be limited. The drug was studied during sessions in the presence of a psychotherapist and, for safety, by a second therapist, taking into account the vulnerability of the patients. The FDA staff’s analysis proposed some limitations on approving the drug, including that it be administered only in certain settings, that patients be monitored and that side effects be tracked.

But doctors and therapists could still prescribe MDMA off-label, expanding its potential for treating other illnesses like depression or anxiety.

Although the two studies that support Lykos’ application suggest that MDMA therapy has led to significant improvements for PTSD patients, a May 31 FDA staff report highlighted flaws in the study designs. Most notably, the report highlighted the high percentage of participants able to determine whether they had received MDMA or a placebo, a phenomenon common to many drug trials involving psychoactive compounds.

The Institute for Clinical and Economic Review, a nonprofit that examines drug costs and effectiveness, criticized the studies and called the results “inconclusive.”

Overall, the FDA’s analysis was largely positive, noting that participants “experienced statistically significant and clinically meaningful improvement in their PTSD symptoms, and this improvement appears to be durable for at least several months.”

A number of ongoing studies are exploring the potential of MDMA to treat a wide range of difficult-to-treat mental health conditions, including obsessive-compulsive disorder and major depression.

Dr. Joshua Gordon, director of the National Institute of Mental Health, said early data on MDMA and other psychedelic compounds electrified the field of psychiatry, particularly research suggesting they can lead to lasting benefits after just a handful of treatments.

But he warns against excessive hope. “MDMA therapy has the potential to be at least as effective as other agents we have, and its effects may last for some time,” he said. “But it won’t work for everyone. It’s not a miracle drug.

News Source : www.nytimes.com
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Sara Adm

Aimant les mots, Sara Smith a commencé à écrire dès son plus jeune âge. En tant qu'éditeur en chef de son journal scolaire, il met en valeur ses compétences en racontant des récits impactants. Smith a ensuite étudié le journalisme à l'université Columbia, où il est diplômé en tête de sa classe. Après avoir étudié au New York Times, Sara décroche un poste de journaliste de nouvelles. Depuis dix ans, il a couvert des événements majeurs tels que les élections présidentielles et les catastrophes naturelles. Il a été acclamé pour sa capacité à créer des récits captivants qui capturent l'expérience humaine.
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