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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  • December 13, 2023
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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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  • October 2, 2023
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