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Australia CBD insomnia bod forward

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Bod Australia has announced that it has received ethical approval for a phase 2 clinical trial of a cannabis extract with insomnia patients.

The trial will investigate the effectiveness of the new prospective schedule 3 CBD (Cannabidiol) Formulation for insomnia symptoms.

In December 2020, the Australian Therapeutic Goods Administration (TGA) gave the nod to reduce the timeline CBD Preparations for Table 3 Pharmaceuticals only, meaning these products will be available without a prescription from February 1, 2021.

However, none have emerged so far as many obstacles must be removed in order for the drug to be granted S3 status. Among other criteria, the drug must be shown to be effective in treating whatever condition or symptom it targets and within dosage limits. To be legally supplied without a prescription, it must also be listed on the Australian Register of Therapeutic Goods (ARTG)

Bod is approaching one such hurdle with this initiative, which will include a double-blind, randomized, placebo-controlled trial of the effect of administering an oral CBD product 50 mg and 100 mg daily over 8 weeks compared to a placebo with more than 200 participants.

To be performed at the Woolcock Institute of Medical Research, ethical approval has been given by Bellberry Limited. The approval allows the company to immediately begin recruiting participants for the study. With insomnia being so common, there is no doubt that it will be of much interest.

“Given the persistent problems associated with pharmacological interventions designed to treat insomnia, we are confident that there will be strong demand to participate in our trial,” Bod Australia CEO Jo Patterson said:.

Pending trial results, it will enable Bod Australia to file an application with the TGA for an S3 designation – potentially seeing the company as one of the first ASX companies to register a Schedule 3 CBD product for use in Australia. The first mover advantage is important, and there are plenty of Australians eager to get into S3 CBD medications.

Bod says this will open up another channel of marketing and have the potential to significantly boost local Bod sales, supporting additional revenue growth.

“..we have engaged in many encouraging discussions with both our existing distribution networks and potential new partners to offer immediate sales upon registration,” said Ms. Patterson.

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