Australian medical cannabis company Bod Science Limited (ASX:BOD) has provided preliminary top-line results from its phase IIB clinical trial of a potential Schedule 3 CBD (cannabidiol) product for the local market.
In late 2020, Australia’s Therapeutic Goods Administration (TGA) announced it would down-schedule certain cannabidiol (CBD) preparations to Schedule 3 (Pharmacist Only) medicines – meaning these would be available over the counter (OTC) from pharmacies without a prescription.
It has been legal to buy qualifying Schedule 3 CBD medicines without a prescription in Australia since February 2021. But more than two years on, S3 products are yet to be made available. Several companies have been racing to be the first to get an OTC CBD product to market, and among them is Bod Science.
Bod’s trial assessed the efficacy of a potential Schedule 3 CBD formulation on symptoms associated with insomnia. 208 participants received daily doses in the double-blind study of either CBD 50mg, CBD 100mg, or placebo for an 8-week period.
Analysis of the primary endpoint showed a statistically significant benefit of CBD 100mg compared to placebo when tested at the 0.05 statistical significance level (p-value), meaning a 5% risk that the results occurred by chance. But it’s worth noting neither CBD dose was shown to be statistically different from placebo at a p-value of 0.025.
The 100mg dosage is important as one of the criteria for an S3 CBD product is that it must be proved to be beneficial in treating or managing the target condition in doses up to a maximum of 150 mg/day.
Safety and tolerability of CBD doses were also assessed in Bod’s trial, and the company says no safety concerns were identified.
Complete results from the study are expected within 5 weeks, and these will also include results from other endpoints: relief from anxiety and stress.
Commenting on the results, Bod Science says it plans to continue commercialisation discussions and meetings with the Therapeutic Goods Association (TGA) to discuss pathways towards Schedule 3 registration.
“The trial completion marks a significant breakthrough for Bod for our uniquely formulated Schedule 3 CBD product,” said Bod Science CEO Ms. Jo Patterson. “As we know, sleep is so central to our health and wellbeing, and the birth of this new product is certainly an exciting journey not only for our business but the cannabis market more broadly.”
And what makes this product unique?
“The singularity of this product is in its’ soft gel format – utilising a patent protected encapsulation technology, presents enormous opportunity both through existing permitted pathways, and through other global markets,” stated Ms. Patterson.
