Avecho Biotechnology initiated a Phase 3 clinical trial for its CBD TPM-enhanced soft-gel capsule, targeting insomnia treatment.

The trial, involving 519 participants across Australian cities like Melbourne, Sydney, and Perth, will assess the efficacy of nightly doses (75mg and 150mg) compared to a placebo over eight weeks.

The trial incorporates advice from sleep and regulatory experts and is designed to meet international regulatory standards, including those of the Therapeutic Goods Administration, the Food and Drug Administration, and the European Medicines Agency.

Completion of this trial is pivotal for Avecho's CBD TPM soft-gel capsule registration with the TGA. Avecho aims to offer a novel, over-the-counter insomnia treatment.

The trial has attracted significant public interest, with 135 participants meeting the inclusion criteria for dosing.