CBD Insomnia Clinical Trial Researchers Seeking to Recruit 500 Patients in Australia

Avecho Biotechnology Limited (Avecho) announced in a recent press release that the company is looking to recruit Australians for a clinical trial exploring the use of a pharmaceutical cannabidiol (CBD) product for insomnia (1).

Researchers are interested in recruiting more than 500 patients from various sites throughout Australia in Perth, Sydney, Melbourne, and Gold Coast. The placebo-controlled clinical trial will investigate Avecho’s proprietary Tocopheryl Phosphate Mixture (TPM) oral soft-gel capsules taken at night over the course of eight weeks and at doses of 75 mg and 150 mg of CBD, as well as a placebo (1).

Prior to the company’s patient recruitment, in a March 2025 press release, Avecho Biotechnology Limited (Avecho) disclosed that they entered into a 10-year license and development agreement with Sandoz Group AG (Sandoz) for the “commercial rights to Avecho’s Phase III cannabidiol (CBD) capsule for insomnia in Australia,” (2). Through the agreement, Avecho can retain the rights to commercialize the CBD capsule in “all other territories”. Sandoz has received a “first right of refusal” in these markets.

The cannabinoid CBD has shown potential in the treatment of conditions such as, epilepsy, anxiety, insomnia, and pain (1). CBD therapeutics has experienced various difficulties that include stability of product shelf-life, limited bioavailability, and pharmaceutical dosage formulations.

“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 (1).

According to the press release (1), insomnia affects 10-30% of the global population, 10-15% of insomnia-sufferers are listed as chronic. Australia has reported that 60% of their population experience insomnia and has an anticipated cost to their economy of around $19.1 billion caused from poor sleep, with productivity loss contributing $11 billion in economic cost loss.

In 2020, the Australian Therapeutics Goods Administration (TGA) allowed for oral CBD products to be registered in the country as over the counter (OTC) medicines, allowing for easier access for consumers (1).

“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 (1).

References

1. Avecho Biotechnology. Sleep health week: Researchers recruiting now for CBD insomnia trial https://www.prnewswire.com/apac/news-releases/sleep-health-week-researchers-recruiting-now-for-cbd-insomnia-trial-302526968.html (accessed Aug 13, 2025).
2. Colli, M. Exclusive License and Development Agreement signed by AVECHO and Sandoz for the commercialized use of CBD for insomnia in Australia https://www.cannabissciencetech.com/view/exclusive-license-and-development-agreement-signed-by-avecho-and-sandoz-for-the-commercialized-use-of-cbd-for-insomnia-in-australia (accessed Aug 13, 2025).