Bod Australia has enrolled the first patients for a Phase IIB clinical trial investigating the efficacy of a Schedule 3, over-the-counter CBD formulation on symptoms associated with insomnia.
The double blind, randomised, placebo-controlled trial, conducted at Sydney’s Woolcock Institute of Medical Research, will investigate the effect of administering a 50mg and 100mg oral CBD product per day over an eight-week period with more than 200 participants.
Bod said once the trial is completed, it is confident “it will have sufficient data to progress product registration for a Schedule 3 low-dose CBD product with the Therapeutic Goods Administration and for the final product to be added to the Australian Register of Therapeutic Goods”.
CEO Jo Patterson said the move was an important milestone for the company.
“We expect that it will provide us with sufficient data to progress product registration and commercialise a new, low-dose CBD product for the Australian market that does not have the major liabilities associated with current pharmacological interventions for insomnia, including abuse, dependence and hangover effects.”
She added: “Data generated from the initiative will also allow Bod to progress product registrations with the US FDA and European EMEA Union, significantly broadening [its] international footprint.”
Patient recruitment is ongoing.
