Avecho has commenced patient recruitment for its Phase III clinical trial examining a low-dose CBD soft-gel capsule as a treatment for insomnia.
The company described the trial as the largest study of its kind targeting insomnia, with plans to enrol 519 patients across Melbourne, Sydney, the Central Coast, Brisbane and Perth.
The study will pit nightly doses of Avecho's TPM-enhanced CBD soft-gel capsule — at 75mg and 150mg — against a placebo over an eight-week dosing period. TPM (Tocopheryl Phosphate Mixture) is the company's proprietary drug-delivery technology.
Avecho received ethics approval for the trial earlier this month following amendments it submitted to the Therapeutic Goods Administration (TGA) in December 2023.
In a statement to the ASX, Avecho said it was "focused on proving the efficacy of its enhanced cannabidiol formulation to become the first company to commercialise a cannabidiol treatment for insomnia as a registered pharmaceutical medicine".
Although the TGA down-scheduled low-dose CBD in December 2020, no product has yet been listed on the Australian Register of Therapeutic Goods to allow over-the-counter pharmacy sales. Sleep-focused trials of CBD have so far produced disappointing results.
Avecho CEO Dr Paul Gavin said the firm "will aim to prove, with meticulous trial design and regulatory compliance, a place for CBD in the treatment of insomnia," with interim analysis results anticipated before the end of 2024.
Principal investigator associate professor Darren Mansfield added: "Existing over-the-counter medications for insomnia either have poor efficacy or are associated with a high degree of next-day impairment.
"There is currently an unmet treatment need for an over-the-counter, effective, fast-acting treatment for insomnia that provides natural, restorative sleep. It is important to establish what role cannabidiol might play… in the future."
