A New Zealand psychiatrist has been granted approval to prescribe psilocybin for patients with treatment-resistant depression, marking the first time the psychedelic drug will be used outside of clinical trials in the country.
Medsafe, New Zealand’s medicines regulator, has approved the unnamed psychiatrist to prescribe, supply and administer medicinal psilocybin to patients diagnosed with the severe condition. The decision provides new treatment options for people who have exhausted conventional therapies.
Associate Health Minister David Seymour described the policy change as a “real breakthrough” for patients with depression who “have tried everything else and are still suffering”.
“If a doctor believes psilocybin can help, they should have the tools to try,” Mr Seymour said on Wednesday.
The approval comes with strict safeguards to ensure appropriate use of the drug. The psychiatrist must follow a defined process, including detailed clinical assessments and consideration of any potential history of medicine misuse. Rigorous record-keeping and reporting requirements to Medsafe have also been implemented.
The approved psychiatrist is highly experienced in prescribing psilocybin and has been administering it safely in clinical trials. However, only this single practitioner is authorised to prescribe the drug at present.
Other clinicians wishing to prescribe psilocybin must seek separate approval from Medsafe. The regulator is developing guidance to assist with future applications, which will be considered based on patient safety and the prescriber’s experience and skill level.
Psilocybin remains an unapproved medicine in New Zealand and is classified as a Class A controlled drug, meaning its supply and use is heavily restricted. No approved products containing psilocybin exist in the country, as the drug has not been assessed by Medsafe for safety and effectiveness.
The compound, found naturally in certain mushroom species commonly known as “magic mushrooms”, has shown promising results in treating depression. Studies have found that a single dose of psilocybin can treat the symptoms of major depression after just one dose.
New Zealand joins Australia, which approved the psychiatric use of psilocybin in 2023, in allowing restricted medical access to the psychedelic. Switzerland permits compassionate use of psilocybin for medical purposes, while Oregon and Colorado in the United States have legalised and regulated therapeutic use.
