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3 clusters · 27 sources · 27 days · First seen · Last updated

Global regulatory progress for MDMA-assisted therapy

Overview

Regulatory developments regarding MDMA-assisted therapy for post-traumatic stress disorder (PTSD) have progressed in both the United States and New Zealand.

In the United States, Resilient Pharmaceuticals resubmitted a New Drug Application (NDA) to the FDA for MDMA-assisted therapy. This resubmission seeks to address previous regulatory concerns regarding safety characterization and bias mitigation using existing data, rather than conducting new Phase 3 trials. This follows the FDA’s July 2026 publication of final guidance on psychedelic drug clinical investigations.

Concurrently, New Zealand’s Medsafe has authorized two psychiatrists—Gary Wynn in Wellington and Tom Paterson in Auckland—to prescribe pharmaceutical-grade MDMA for severe PTSD. This decision makes New Zealand the second country to authorize such use, following Australia’s 2023 authorization. The treatment is restricted to authorized clinicians who must follow strict therapeutic protocols within a controlled clinical setting for patients aged 18 and older; patients are not permitted to take the substance home.

Associate Health Minister David Seymour supported the authorization, stating that ‘PTSD ruins lives and is difficult to treat’ and suggesting MDMA could be highly effective through psychedelic-assisted therapy. This move follows research, including Phase 3 trials by the Multidisciplinary Association for Psychedelic Studies, which indicated significant symptom reduction. This development stands in contrast to the U.S. Food and Drug Administration’s 2024 decision to reject MDMA for medical use due to insufficient evidence regarding safety and efficacy.

Entities

Multidisciplinary Association for Psychedelic Studies · Medsafe · David Seymour · New Zealand · Lykos Therapeutics

Claims

What the coverage asserts, and how many sources carry each claim.

Timeline

  1. 6 days ago

    [HEALTH] 4 sources
    New Zealand approves MDMA for clinical PTSD treatment

    New Zealand has become the second country to approve MDMA for clinical use to treat severe PTSD, authorizing two psychiatrists to prescribe the substance alongside psychotherapy.

  2. 8 days ago

    [HEALTH] 23 sources
    New Zealand authorizes MDMA for severe PTSD treatment

    New Zealand has become the second country, after Australia, to authorize pharmaceutical-grade MDMA for treating severe PTSD, restricted to two psychiatrists under strict clinical supervision.

  3. about 1 month ago

    [HEALTH] 3 sources
    Resilient Pharmaceuticals resubmits MDMA therapy NDA to FDA

    Resilient Pharmaceuticals has resubmitted an FDA application for MDMA-assisted therapy for PTSD without a new Phase 3 trial, following previous regulatory requests for more safety and bias mitigation data.

Sources

apach57.fr · deutschlandsuchtdensuperstar.de · elespectador.com · fehmarn24.de · finance.technews.tw · gulfnews.com · industrywired.com · internacional.estadao.com.br · kreiszeitung.de · kurierverlag.de · lanacion.cl · leinetal24.de · livenews.co.nz · mannheim24.de · mugglehead.com · njtoday.news · normanandozi.com · nuevolaredo.tv · odelalis.gr · op-online.de · pt.euronews.com · techfars.com · tn23.tv · tz.de · veja.abril.com.br · vesti-online.com · zarpanews.gr

This summary has been updated 2 times: see revision history