Avecho has dosed the first patient in a phase III clinical trial testing an oral CBD soft-gel capsule for insomnia using its Tocopheryl Phosphate Mixture (TPM) drug-delivery system.

The trial is targeting 519 patients across sites in Melbourne, Sydney, the Central Coast, Brisbane, and Perth. Treatment groups will compare nightly doses of 75mg and 150mg CBD with placebo over an eight-week dosing period.

Avecho said the trial has been designed to suit the requirements of the Therapeutic Goods Administration (TGA), US Food and Drug Administration and the European Medicines Evaluation Agency.

Dr Paul Gavin

A successful phase III trial is the final clinical step for Avecho in support of a submission 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.”

Prior to launching Cannabiz, Martin was co-founder and CEO of Asia-Pac’s leading B2B media and marketing information brand Mumbrella, overseeing its sale to Diversified Communications in 2017. A journalist...

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