Cann Group is preparing to recruit patients for a phase 3 clinical trial as it continues in its bid to register an over-the-counter product with the Therapeutic Goods Administration (TGA).
The company will conduct a randomised, double blind, placebo-controlled study into the effectiveness of its Satipharm medicine on sleep disturbance.
A minimum of 212 patients will take part with recruitment starting next month.
Participants will be split into four groups and, over a four-week period, receive one of three different doses of Satipharm CBD, or a placebo.
The results are expected later this year as Cann Group works towards lodging a dossier with the TGA.
Sleep and cannabinoid physician Dr Dev Banerjee, who helped design the trial, said existing anecdotal evidence surrounding CBD and sleep needs validating.
“Many products and supplements currently promoted as sleep therapies are not supported with rigorous clinical data,” he said. “It would be a great benefit to have a proven, registered CBD treatment available on a pharmacy-only basis.”
Cann, citing sales figures from MIDAS, said Australians spent close to A$100m on pharmacy-supplied, over-the-counter sleep disturbance products in 2020/21.
Chief operating officer Shane Duncan predicted a flurry of schedule 3 products will hit pharmacy shelves within weeks of each other.
He told Cannabiz Cann’s aim is not necessarily to be the first to market, but the first to get a non-soft gel “advanced delivery capsule” across the line.
“The race that’s going on to be first to market, I reckon there’s only going to be a few weeks between the first and the fifth,” Duncan said. “They’re all going to get registered close together. We’re all probably in the same spot, plus or minus a month.
“Our objective is to be the first advance delivery capsule, so the first non-soft gel. We don’t care if we’re the third, fourth or fifth registered product, we just want to be the first advanced delivery format, the more elegant solution for delivering medicine.”
Assuming trials are successful – which is uncertain given the low doses of CBD involved – it is anticipated the first products could be registered by the TGA before the end of the year, or early in 2023.