During Sleep Health Week (11-15 August 2025), Australians living with insomnia are reminded that a new treatment is on the horizon – with clinical trial sites actively recruiting now.
MELBOURNE, Australia, Aug. 12, 2025 /PRNewswire/ — Avecho Biotechnology Limited (Avecho) is today alerting Australians to recruitment efforts for the largest ever clinical trial (‘the Trial’) for the treatment of insomnia with a pharmaceutical cannabidiol (CBD) product – with clinical trial sites now live across the country.
The Trial is a placebo-controlled study assessing the use of CBD for insomnia, recruiting more than 500 patients across sites located in Melbourne, Sydney, Gold Coast, and Perth. The Trial is comparing nightly doses of Avecho’s proprietary oral soft-gel capsules at doses of 75 and 150mg cannabidiol with placebo over an 8-week dosing period.
CBD is the major non-psychoactive chemical found in the cannabis plant, which shows promise for treating epilepsy, pain, anxiety and insomnia, and more. Avecho has developed a proprietary Tocopheryl Phosphate Mixture or TPM®– enhanced CBD soft-gel capsule to address key challenges in CBD therapeutics – limited bioavailability, a pharmaceutical dosage form, and stability of the compound for an appropriate shelf-life.
The final phase of patient recruitment is now underway, following a significant investment from a major global pharmaceutical Company, Sandoz AG.
“We are delighted to be working closely with a team of dedicated clinical experts across Australia to recruit for the Phase III Clinical Trial for our TPM®-enhanced CBD soft-gel capsule for the treatment of insomnia. This is an exciting opportunity for people who are experiencing insomnia to be among the first people to try this treatment,” said Avecho CEO, Dr Paul Gavin.
Insomnia is estimated to affect between 10-30% of the population globally, with 10-15% of the population classified as chronic. Insomnia can be a symptom of a range of other disorders, particularly mental health and psychiatric disorders, and can contribute to their onset or exacerbation.
In Australia alone, almost 60%[1] of the population reports insomnia symptoms, contributing to an estimated total cost to the Australian economy of $19.1 billion due to poor sleep. Productivity losses account for most of the economic cost, estimated at $11 billion.[2]
Following a key policy change by the Australian Therapeutics Goods Administration (TGA) in 2020, oral pharmaceutical CBD products can be registered in Australia as over the counter (OTC) medicines, a key access and safety advantage over unregistered medicinal cannabis products. This OTC opportunity was initially unique to Australia but was recently adopted by the regulatory authority of New Zealand too.
“Avecho is on track to be the first company to successfully register a pharmaceutical CBD product for sleep anywhere in the world – which, if successful, will be available over the counter at pharmacies in Australia,” said Dr Gavin.
For more information visit avecho.com.au
ACTIVE PATIENT RECRUITMENT SITES, PHASE III INSOMNIA TRIAL
For more information visit avecho.com.au
Griffith University, Clinical Trial Unit – QLD
1 Parklands Drive, Southport QLD 4215
Insomnia Trial
Monash Health – VIC
246 Clayton Road, Clayton VIC 3168
AVE047-22 CBD in Insomnia | MLSI Clinical Trials
Key Health, CBD South – NSW
Ground Floor, 281 Elizabeth Street, Sydney NSW 2000
https://www.keyhealth.com.au/clinical-trials
Pioneer – NSW
Ground Floor, 53 Walker Street, North Sydney NSW 2060
Our Clinical Trials | Pioneer Clinical Research Sydney
Captain Stirling Medical Centre – WA
92 Stirling Highway, Nedlands WA 6009
https://www.csmc.net.au/services/medical-studies-and-clinical-trials
[1] Chronic Insomnia Disorder in Australia: A Report to the Sleep Health Foundation, Sleep Health Foundation, July 2019
[2] Rise and try to shine: The social and economic cost of sleep disorders in Australia, Sleep Health Foundation, Deloitte Access Economics, April 2021
View original content:https://www.prnewswire.com/apac/news-releases/sleep-health-week-researchers-recruiting-now-for-cbd-insomnia-trial-302526968.html
SOURCE Avecho Biotechnology
