Australia’s Cann Group (ASX:CAN) has entered into an agreement aiming to accelerate registration of a Schedule 3, over-the-counter cannabidiol (CBD) medicine in Australia.
While it has been legal to buy certain low-dose CBD medicines without a prescription in Australia as Schedule 3 (Pharmacist Only) since February this year, these products must be listed on the Australian Register of Therapeutic Goods. Listing is a complex, lengthy and expensive process, which is why there are no products yet available and likely won’t be until late this year or early next year.
The race is on between a number of companies to be the first.
The collaboration with Emyria’s EMD-003 drug development program will see Cann Group’s Gelpell microsphere technology, acquired via the purchase of the Satipharm group of companies last month, as the basis for seeking a Schedule 3 ARTG listing.
This arrangement provides a head start given Phase 1 trials are already completed for 10mg and 100mg doses of the Satipharm capsule. Emyria has real-world data on more than 170 patients taking it and has prepared protocols for clinical trials for the target indication.
As for what the target indication is, it was noted as being for “treating unmet needs in mental health”, specifically for psychological distress and symptoms of depression, anxiety and stress.
“We anticipate there will be a large patient demand for a TGA registered CBD medicine that is convenient to patients and demonstrates the highest standards of quality, safety and efficacy,” said Cann Group CEO Peter Crock.
Mr. Crock also mentioned the company was working towards bringing the Gelpell pharmaceutical GMP manufacturing line to Cann’s Mildura production facility; which will be commissioned at the end of this year.
Gelpell technology involves embedding CBD in tiny seamless gelatine beads that protect the CBD from heat, light and oxygen. The beads are put into capsules that protect the beads from stomach acids, instead dispersing them throughout the intestine where they are absorbed by the body into both the bloodstream and the lymphatic system.
In other recent news from Cann Group, the company announced it had commenced a civil proceeding in the High Court of the Hong Kong Special Administrative Region in connection to the loss of EUR2.25m (approximately AU$3.47m) in a cybersecurity incident in February.