Clinical Research

Helius Therapeutics to Supply New Phase 2 Cannabis Sleep Trial

Helius Therapeutics has today announced a supply agreement with the University of Auckland for a new Phase 2 trial into cannabis as a sleep aid for patients which chronic back pain.

Helius Therapeutics has today announced a supply agreement with the University of Auckland for a new Phase 2 trial into cannabis as a sleep aid for patients which chronic back pain. 

The New Zealand medicinal cannabis company will supply the study medicine and placebo for the ‘CPS Trial’ (Cannabis, Pain, Sleep). 

Set to be conducted by researchers at Tuaranga Hospital, the University of Otago and the University of Auckland, seven-month study will measure the effectiveness of a cannabis-derived medicine as a long-term sleep aid, and has already been registered on the Australian New Zealand Clinical Trials Registry as a randomised, double-blind, placebo-controlled crossover trial.

It comes just weeks after Ora Pharm completed its acquisition of Helius business and key operating assets, creating the largest end-to-end medical cannabis and hemp supply chain in New Zealand. 

As part of the deal, all Helius’ relevant licences and product registrations have been handed to Ora, while its EU-GMP manufacturing facility and established prescriber and distribution relationships have been integrated into Ora’s national network and global export capability. 

CPS’ lead investigator Dr Saad Anis, a Specialist Pain Medicine Physician and Anaesthetist at Tauranga Hospital, said more than one in five New Zealand adults live with chronic non-cancer pain, with international research suggesting around three-quarters of them also experience disrupted sleep.

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“People living with pain tell us that poor sleep is one of the things that affects their quality of life the most,” said Anis. “Many want to try cannabis-derived medicines, but I find them difficult to recommend given the current state of the evidence. Our experienced team designed this study to provide high-quality evidence of whether there is a benefit over the long-term, and help doctors make informed decisions with their patients.”

Each trial participant will take the study medicine at bedtime for three months and a placebo for three months in random order, with sleep patterns monitored throughout via a wrist-worn device. The primary outcome is a change in Insomnia Severity Index score, with wrist actigraphy measures as a secondary outcome. 

The trial is being funded by the University of Auckland and an Australian and New Zealand College of Anaesthetists Novice Investigator Grant, with ethics approval from New Zealand’s Health and Disability Ethics Committees. 

Medicinal cannabis prescribing in New Zealand remains concentrated in specialist clinics. Massey University’s 2025 NZ Drug Trends Survey, which drew 8,883 respondents, found that 83% of surveyed medicinal cannabis users with a prescription reported obtaining it through a cannabis clinic, against 21% who reported a GP prescription source. 

“New Zealand’s medicinal cannabis sector is growing, but clinical trial data is still needed to build confidence in cannabis medicines in general practice,” said Helius Therapeutics Chief Executive Officer Zoë Reece. 

“We see independent studies like the CPS trial as essential building blocks in the sector’s long-term development and increasing medicinal cannabis’ share of prescriptions over time.

“New Zealand has built a reputation as a centre of excellence for clinical research, and we expect this study to carry weight with pain specialists both here and abroad.”

Dispensings under New Zealand’s Medicinal Cannabis Scheme, which came into effect on April 01, 2020, have grown from 4,875 in 2020 to 389,668 in 2025, according to Health New Zealand. Eighty medicinal cannabis products have met the Scheme’s minimum quality standard since it began, including 25 in 2025.

Results from the CPS Trial are expected to be published in early 2028.

TopicsChronic PainHelius Therapeuticsnew zealandOra PharmUniversity of Auckland

Ben Stevens

Ben is the editor of Business of Cannabis. Since 2021, he has researched, written, and published the vast majority of the outlet’s content, delivering agenda-setting journalism on regulation, business strategy, and policy across Europe.

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