Bod Australia has announced its planned phase IIB clinical trial of a cannabis extract with insomnia patients has received ethics approval.
The trial will investigate the efficacy of a new prospective Schedule 3 CBD (cannabidiol) formulation on insomnia symptoms.
In December 2020, Australia’s Therapeutic Goods Administration (TGA) gave the nod to down-scheduling certain CBD preparations to Schedule 3 – Pharmacist Only medicines, meaning such products would be available without a prescription from February 1, 2021.
However, none have yet appeared as many hurdles need to be cleared for a medicine to be granted S3 status. Among other criteria a medicine has to be shown to be effective in treating whatever condition or symptom it is targeting and within the dosage limitations. To be legally supplied without a prescription, it must also be listed on the Australian Register of Therapeutic Goods (ARTG)
Bod is approaching one of these hurdles with this initiative, which will involve a double blind, randomised and placebo-controlled trial of the effect of administering a 50mg and 100mg oral CBD product daily over a 8-week period compared to placebo with more than 200 participants.
To be undertaken at the Woolcock Institute of Medical Research, the ethics approval was granted by Bellberry Limited. The approval allows the company to immediately commence participant recruitment for the study. With insomnia being quite common, no doubt there will be plenty of interest.
“Given the ongoing issues associated with pharmacological interventions designed to treat insomnia, we are very confident that there will be strong demand to participate in our trial,” said Bod Australia CEO Jo Patterson.
Pending results of the trial, it will enable Bod Australia to submit an application to the TGA for S3 classification – and potentially see the company one the first ASX-listed firms to register a Schedule 3 cannabidiol product for use in Australia. The first-mover advantage is important, and there are plenty of Australians eager to access S3 CBD medicines.
Bod says this will unlock another channel to market and has the potential to significantly boost Bod’s domestic sales, underpinning additional revenue growth.
“.. we have engaged in numerous encouraging discussions with both our existing distribution networks and new potential partners to provide immediate sales upon registration,” said Ms. Patterson.