MDMA’s potential shift from party drug to PTSD therapy could hinge on strict safety measures

MDMA, the stimulant mood-lifting drug commonly known as ecstasy, could soon transition from party staple to FDA-approved medication — but likely with tight control measures to address its abuse potential and safety risks.

On Tuesday, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) filed an application seeking FDA approval of MDMA-assisted therapy for post-traumatic stress disorder, based on positive phase 3 results demonstrating significant PTSD reductions for most trial participants. In the studies, a significant number of those receiving MDMA-assisted therapy no longer qualified for a PTSD diagnosis after three treatment sessions, with a large majority seeing clinically meaningful improvements.

Currently, the Drug Enforcement Administration (DEA) categorizes MDMA as a Schedule I controlled substance having no approved medical uses, although it is likely to reclassify the stimulant if it receives FDA approval.

MAPS founder Ric…

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A century after its synthesis, MDMA could be headed for FDA approval for PTSD

First synthesized in 1912 by Merck, the empathogenic drug 3,4-Methylenedioxymethamphetamine (MDMA) is inching toward FDA approval following the positive results of a phase 3 study. The recently concluded phase 3 study, MAPP2, published in Nature Medicine, found that MDMA-assisted therapy significantly outperforms traditional talk therapy in reducing PTSD symptoms. Participants receiving MDMA-AT had an 86.5% response rate (≥10-point reduction in PTSD symptoms), compared to a 69.0% response rate among participants receiving therapy with placebo. Equally impressive, 71.2% of the MDMA-AT participants no longer met the PTSD criteria post-treatment, in contrast to the 47.6% in the placebo with therapy group. At the close of the trial, 46.2% of the MDMA-AT participants met the remission criteria in contrast to the 21.4% in the placebo with therapy group.

MDMA’s efficacy in PTSD treatment // Load the Visualization API and the corechart package. google.char…
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MAPS predicts FDA approval for MDMA-assisted therapy in 2024

The Multidisciplinary Association for Psychedelic Studies (MAPS) founder and executive director, Rick Doblin, said in an interview with Fox Business Live that the FDA would approve MDMA-assisted therapy for PTSD in April or May of 2024.

Last year, MAPS announced the completion of the MAPP2 Phase 3 study, which is the organization’s second to use MDMA (3,4-methylenedioxymethamphetamine) therapy for PTSD treatment. The organization anticipates releasing data from the study in the first quarter of 2023.

In the Fox interview, Doblin said that the MAPP2 study achieved confirmatory results for treating PTSD.

Doblin underscored the importance of therapy in the Phase 3 trial. “It’s the therapy that is the primary active treatment, and the MDMA, the medicine, makes the therapy more effective,” he said in the interview.

He also noted that the Veterans Administration pays billions of dollars annually for disability, including for veterans with PTSD. Accordin…

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Debate series considers the promise and pitfalls of psychedelics

Photo by Sergey Katyshkin from Pexels

Intelligence Squared, the organizers of a popular debate series, recently asked a panel of experts whether psychedelics should be legalized. There was considerable overlap between the factions arguing in favor and opposition of that motion, reflecting the growing interest in psychedelic compounds for therapeutic applications. But the two camps were split when it came to the best regulatory model for psychedelic drugs.

“I advocate strongly that [psychedelics] be allowed to be studied for medical research to see what their therapeutic indications are and how they can help us to understand the brain and the mind,” said Dr. Jeffrey Lieberman, the chair of Columbia University’s department, who argued against the motion.

Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), argued for a more permissive approach that would a…

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