‘Another level’: Race on to get over-the-counter cannabis meds to pharmacies
ASX-listed cannabis companies are racing to get low-dose medicinal pot products onto shelves, with hopes they will be available through pharmacies by the end of next year.
In February, the country’s medicines regulator - the Therapeutic Goods Administration (TGA) - agreed to change the classification for certain products containing small amounts of cannabidiol (CBD), an active ingredient in the cannabis plant that does not get the user high but is used in therapeutic products.
Under the new rules, cannabis medicines in this category are classified as “schedule 3” medicines and can be sold in pharmacies without the need for a prescription. However, no Australian products currently fit the criteria for an over-the-counter medicine, meaning drug developers must set up clinical trials for new products and show that they work before anything can be sold to consumers.
Cann Group is optimistic it can be one of the first producers to bring a “schedule 3” drug to market. CREDIT: NINE “The interest in medicinal cannabis is strong, and it continues to grow,” said chief executive of ASX-listed cannabis company Cann Group, Peter Crock. “The schedule 3 [pharmacy] product is going to take things to another level.”
Cann Group is currently building a cannabis production facility in the Victorian regional town of Mildura, which it hopes to be commissioned by the end of this year and will generate 12,500 kilograms of medicinal cannabis dry flower every year once it is finished.
It also bought a cannabis brand called Satipharm earlier in 2021. Satipharm already provides CBD capsules under Australia’s special access scheme, which lets doctors prescribe cannabis medicines to patients in certain circumstances for a range of illnesses, including chronic pain.
The TGA says there is scientific evidence to support the use of CBD capsules to treat chronic pain, anxiety and sleep issues, but any over-the-counter medicines will have to provide robust evidence that they work for one particular ailment.
Cann has not yet revealed what illness it plans target first with its therapy.
Fellow ASX-listed biotech Emyria is also aiming to be one of the first Australian companies to register an over-the-counter treatment. It has told investors it plans to complete clinical trials next year for a product known as EMD-003, a synthetic cannabis pill to treat psychological pain.
Chief executive Dr Michael Winlo said in a research presentation last month the company hopes to have its product registered for use by the end of next year.
“We know we are targeting a major unmet need in psychological distress,” he said.
Australia’s medicinal cannabis sector is worth more than $2 billion combined and the decision to allow some products to be sold at the pharmacy level will help companies capture more consumers. In the US, consumers are set to spend $US23 billion ($30 billion) a year on legal cannabis by 2025, according to projections from business insights firm Statista. Mr Crock said that there would be a significant lag between the Australian regulator’s decision to allow low-dose cannabis products and these products coming to market because companies have to provide strong evidence from clinical trials before they registered products for sale.
“It means it will be well into 2022 before any product comes through... that’s probably the key thing.” Originally published here: https://www.smh.com.au/business/companies/another-level-race-on-to-get-over-the-counter-cannabis-meds-to-pharmacies-20210907-p58pex.html