New Zealand becomes second country to approve MDMA for severe PTSD
New Zealand's medicines regulator, Medsafe, has authorised two named psychiatrists to prescribe MDMA-assisted therapy to adults with severe post-traumatic stress disorder, making it only the second country after Australia to allow the drug's clinical use. The decision follows a 2024 US rejection of a similar application and draws on two MAPS-run Phase 3 trials in which most participants no longer met PTSD diagnostic criteria after treatment paired with psychotherapy.
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Medsafe authorises two psychiatrists to prescribe MDMA for severe PTSD
New Zealand's medicines regulator, Medsafe, has authorised MDMA-assisted therapy for adults with severe post-traumatic stress disorder, becoming only the second country after Australia to allow the drug's clinical use. The prescribing authority is limited to two named psychiatrists rather than psychiatry generally: Euronews reports the approvals went to Wellington-based Dr. Gary Wynn and Auckland-based Dr. Tom Paterson. Under the conditions Medsafe and New Zealand's Ministry of Health set, pharmaceutical-grade MDMA can only be given inside a controlled clinical setting alongside structured psychotherapy sessions, patients must be 18 or older, and no doses can be taken home. The approach keeps MDMA paired with therapy rather than treating it as a standalone medicine, and confines prescribing to specialists who completed New Zealand's regulatory process.[1], [2]
New Zealand's approval follows Australia's 2023 move and a 2024 US rejection
New Zealand's decision follows Australia's 2023 authorisation of the same treatment and comes two years after the US Food and Drug Administration rejected a similar application, citing insufficient evidence of safety and effectiveness. Deputy Prime Minister David Seymour, who last year backed a comparable approval for psilocybin to treat severe depression, described PTSD as life-ruining and hard to treat, said MDMA can be very effective when paired with psychedelic-assisted therapy, and framed the move as part of New Zealand's commitment to opening access to new treatments. Existing pharmaceutical options for PTSD in most countries are limited to two antidepressants that can take up to three months to take effect and produce uneven results, a gap that both the New Zealand and Australian approvals were designed to address.[2]
Two MAPS-run Phase 3 trials underpinned the New Zealand approval
The New Zealand approval draws on evidence from two pivotal international Phase 3 trials run by the Multidisciplinary Association for Psychedelic Studies (MAPS) and sponsored by its public-benefit arm, Lykos Therapeutics. In the first trial, published in 2021, 88 percent of participants with severe PTSD who received MDMA-assisted therapy showed clinically significant improvement, and 67 percent no longer met the diagnostic criteria for the condition. A second trial in 2023, involving people with moderate-to-severe PTSD, found that 71.2 percent no longer met PTSD diagnostic criteria by the study's end. Despite those results, US regulators raised concerns that participants who had used MDMA before created an expectancy bias that complicated the trial data, a concern New Zealand's regulator did not cite as a barrier to its own decision.[2]
