Australia’s Little Green Pharma (ASX:LGP) has received Human Research Ethics Approval for a study to support its efforts towards an Australian Schedule 3 cannabidiol (CBD) product registration.
LGP’s Phase III efficacy and safety trial involves the company’s LGP Classic CBD 50 cannabis medicine, which would target stress reduction and improved quality of sleep in healthy adults under a Schedule 3 (Pharmacist-only) registration. While S3 CBD has been legally accessible without a prescription since early 2021, there are no over-the-counter (OTC) CBD medicines available yet in Australia given the regulatory hurdles that first need to be cleared.
But plenty could be on the way given the number of companies jostling to be among the first to gain the coveted classification. There’s a significant chunk of change to be made through getting products on pharmacy shelves – LGP notes a forecast that the Pharmacist-only CBD market in Australia is expected to reach $250 million and over 2 million consumers when the market meets maturity.
Commenting on the ethics approval for the company’s trial, LGP CEO Fleta Solomon said:
“This represents a significant milestone for Australian patients along the pathway to ultimately accessing Australian made CBD products at their local pharmacy ‘over the counter’”
LGP says the company is now considering funding and partnering options for what it calls the “SleepWell Study” in order to progress to Schedule 3 CBD product registration.
In other recent news from Little Green Pharma, the company recently released its Half-year Financial Report for the period ended 30 September 2022. Independent Non Executive Chair Michael D Lynch-Bell noted the company saw strong revenue growth during the period. Revenue was $9.2 million, up 25% compared to the 6 months to 31 December 2021 and up more than 130% from the corresponding 6 months to 30 September 2021.
Net loss from ordinary activities dropped from a net loss after tax of $8,577,856 to a net loss after tax of $7,495,460; largely due to the increase in revenue from ordinary activities.
Last month, the Perth-headquartered company celebrated a win in the International Health category at the 60th Australian National Export Awards. This followed an accolade in the WA State Export Awards in October.
