Australia’s Cann Group (ASX: CAN) appears to have experienced a significant setback in its pursuit of registering an over-the-counter cannabidiol (CBD) product.
A number of companies are racing to be the first or among the first to get coveted Schedule 3 (S3) status for low-dose cannabidiol medications in Australia. S3 products are “Pharmacist Only”, meaning a prescription isn’t needed – but counselling and verification by a pharmacist is required before use.
For a company to get a medicine classified as Schedule 3 is no mean feat – it’s an expensive and complex process.
Cann Group is one of the companies seeking to register an S3 product, in the form of low-dose Satipharm CBD capsules targeting the treatment of sleep disturbance.
Back in November last year, Cann announced data entry for its Phase III low-dose CBD clinical trial involving 257 participants had been completed, and it expected to announce initial results early this year. The trial involved three doses of Satipharm CBD capsules compared to a placebo in a randomised, double-blind, multicentre clinical trial.
Those results are in and according to Cann Group, primary end-points have not shown a statistically superior response of the Satipharm CBD preparation compared to placebo for treating sleep disturbance.
“Cann Group expects these trial results will delay submission of the registration application to the Therapeutic Goods Administration (TGA) for this indication,” stated the company.
Cann is awaiting delivery of the full data set, and after evaluation of that the firm will review its approach for the sleep disturbance indication, and update the market.
There wasn’t much in terms of further commentary from the company, but no doubt it’s been a disappointing turn of events – for the firm, its shareholders and Australians who were holding out hope for such a product to be available from their local pharmacy fairly soon.
It was back in late 2020 when Australia’s Therapeutic Goods Administration (TGA) announced a final decision on down-scheduling low-dose CBD, and products could have been (technically) available from February 2021. But nearly two years on, they are yet to appear on pharmacist’s shelves.