Recruitment has begun for Avecho’s Phase III clinical trial testing its low-dose CBD soft-gel capsule in the treatment of insomnia.
Avecho claimed the trial is the largest insomnia study of its kind, seeking to recruit 519 patients across sites in Melbourne, Sydney, the Central Coast, Brisbane and Perth.
It will compare nightly doses of the firm’s CBD, TPM-enhanced soft-gel capsule at doses of 75mg and 150mg with placebo over an eight-week dosing period. TPM (Tocopheryl Phosphate Mixture) is Avecho’s proprietary drug-delivery system.
The firm received ethics approval for the trial earlier this month after submitting amendments to the Therapeutics Goods Administration (TGA) in December 2023.
Avecho told the ASX 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”.
Despite the TGA down-scheduling low-dose CBD in December 2020, no product has yet been included on the Australian Register of Therapeutic Goods enabling over-the-counter pharmacy sales. Sleep trials of the medicine have so far proven disappointing.
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 expected by 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.”
