Cann Group Limited (ASX: CAN) announced on Monday data entry for the company’s Phase III low-dose CBD clinical trial has been completed.
The race is on in Australia among a number of medical cannabis companies vying to be the first to get the regulatory green light for cannabidiol (CBD) medicines that don’t require a prescription.
It has been legal to buy certain CBD medicines without a prescription in Australia as Schedule 3 (Pharmacist Only) products since February last year after Australia’s Therapeutic Goods Administration (TGA) announced a final decision on down-scheduling low-dose CBD in late 2020. But medicines are yet to appear in pharmacies as there are a bunch of regulatory hurdles that must be cleared before a product can achieve the coveted S3 status.
Cann Group is one of the companies in the race with its proprietary Satipharm CBD capsules, targeting the treatment of sleep disturbance.
Cann says 257 participants have completed the Phase III trial, well beyond the company’s initial target of 212. The final participant enrolled in the trial has attended their last study visit. As for the results of the study, they’ll be revealed in the “coming weeks”, previously noted by Cann Group as early 2023.
Cann Group CEO Peter Crock said:
“This is a great achievement as part of our over-the-counter CBD strategy, and shows how quickly we are working towards a definitive outcome.”
In April this year, GSK Consumer Healthcare (trading as Haleon), secured an exclusive evaluation and option agreement with Cann for the marketing and sale of Satipharm CBD capsules in Australia, and potentially other markets around the world. Early this month the parties subsequently agreed to and signed a non-binding commercial term sheet.
After the results of the trial are made available, Haleon will determine if it wishes to take up its option to market and distribute Satipharm CBD.
Satipharm CBD 50mg capsules, which feature “gelpell” technology, are currently only available in Australia through the Therapeutic Goods Administration (TGA) Special Access Scheme (Category B) or through the Authorised Prescriber Scheme. As things currently stand, the medicine is not approved in Australia for any specific indication.