Avecho has administered its first patient dose in a phase III clinical trial evaluating an oral CBD soft-gel capsule for the treatment of insomnia, with the therapy delivered via the company's Tocopheryl Phosphate Mixture (TPM) drug-delivery system.
The trial is targeting 519 patients across sites in Melbourne, Sydney, the Central Coast, Brisbane, and Perth. Participants will be assigned to nightly doses of either 75mg or 150mg CBD, or a placebo, over an eight-week dosing period.
Avecho said the trial has been designed to meet the requirements of the Therapeutic Goods Administration (TGA), the US Food and Drug Administration, and the European Medicines Evaluation Agency.
A successful phase III outcome would be the final clinical step required before Avecho can submit an application to the TGA to register the medicine for over-the-counter sales in pharmacies.
CEO Dr Paul Gavin said: “We are thrilled to commence dosing patients on our pivotal phase III insomnia trial, marking a significant milestone not only for Avecho, but also for the potential relief of millions suffering from this debilitating condition.
“This trial is central in our quest to offer the first over-the-counter CBD-based insomnia treatment in Australia.
“Our commitment to rigorous scientific validation and patient safety is at the core of this effort, and we are optimistic about leading the way in providing a new, effective option for insomnia sufferers.”
