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Avecho is pleased to announce that the first patient has been dosed in its Phase III clinical trial testing its oral CBD TPM®-enhanced soft-gel capsule for insomnia.

The trial is the largest of its kind testing cannabidiol and has been designed to suit the requirements of the Australian Therapeutic Goods Administration (TGA), US Food and Drug Agency and the European Medicines Agency, aided by advice from international sleep and regulatory experts.  The trial target is 519 participants across multiple Australian cities including Melbourne, Sydney, Brisbane, Central Coast, and Perth.

“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, leveraging Australia’s regulatory changes. 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.”

First Patient dosed in Phase III insomnia trial

Announcement summary