Two psychiatrists in New Zealand can now prescribe MDMA in controlled clinical settings, built on trial results that have been challenged in the US.
Two New Zealand psychiatrists have won approval to prescribe pharmaceutical-grade MDMA to patients with severe post-traumatic stress disorder, making the country only the second in the world - after Australia in 2023 - to authorise the party drug for clinical use.
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New Zealand's medicines regulator, Medsafe, granted the approvals to Wellington's Dr Gary Wynn and Auckland's Dr Tom Paterson, who spent more than a year passing the regulatory process.
"PTSD ruins lives and is difficult to treat," said Deputy Prime Minister David Seymour, who last year backed a similar approval for psilocybin, the active compound in magic mushrooms, to treat severe depression.
"MDMA can be very effective at treating it through psychedelic-assisted therapy," he said, adding that New Zealand remains committed to opening access to "innovative treatments."
PTSD develops after a person experiences or is threatened by traumatic events such as combat, sexual assault or sudden death.
Existing pharmaceutical options in most countries are limited to two antidepressants that can take three months to take effect and produce uneven results.
The evidence behind the approval — and why the US said no
The approval draws on evidence from two pivotal international Phase 3 trials, run by the US-based Multidisciplinary Association for Psychedelic Studies (MAPS) and sponsored by its public benefit corporation arm Lykos Therapeutics.
In the first, published in 2021, 88% of participants with severe PTSD who received MDMA-assisted therapy showed clinically significant improvement, and 67% no longer met the diagnostic criteria for PTSD.
A second trial in 2023, involving participants with moderate-to-severe PTSD, found 71.2% of those treated with MDMA no longer met PTSD diagnostic criteria by the end of the study.
Despite those results, the US Food and Drug Administration rejected the therapy's approval in 2024, citing insufficient evidence of its safety and effectiveness.
Regulators raised concerns that participants who had taken MDMA before produced an expectancy bias, complicating the trial data.
New Zealand's Ministry of Health said the new treatment would be tightly controlled, combining MDMA with psychotherapy in a clinical setting rather than take-home doses.
"Treatment takes place in a controlled clinical setting under the care of an authorised psychiatrist and forms part of a comprehensive treatment plan," the ministry said, adding that patients must be aged 18 or older.
