MEDICINAL cannabis company, Little Green Pharma (LGP), could be the first to deliver a Schedule 3 product to the Australian market, after securing ethics approval for its Phase III SleepWell Study.
The Australian-based, multi-site, placebo-controlled trial will assess the efficacy and safety of the company's LGP Classic 50 cannabis product for stress reduction and improved quality of sleep in healthy adults.
In a statement to the Australian Securities Exchange (ASX) the company reported that if the trial is successful it will support the future registration of the cannabis oil medication as an over-the-counter (OTC) treatment.
LGP CEO, Fleta Solomon, welcomed the ethics approval.
"We are delighted to receive ethics approval for LGP's SleepWell Study, which is yet another significant achievement for the LGP team and its product and drug delivery innovation strategy," Solomon said.
"This represents a significant milestone for Australian patients along the pathway to ultimately accessing Australian-made CBD products at their local pharmacy OTC."
The company said the S3 CBD market was set to reach $250 million and more than two million consumers at market maturity.
Under the current scheduling model, products containing a maximum daily dose of 150mg of CBD can be dispensed OTC, however, there are currently no products that meet that criteria listed on the Australian Register of Therapeutic Goods.
Voicing support for the Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021 in Feb 2021, Federal Health Minister, Mark Butler, said the OTC dosage was "sub-therapeutic".
"For many conditions 150mg a day simply won't do the job," Butler said.
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