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Medical cannabis company Althea Group (ASX:AGH) says a regulatory tweak to the down-scheduling of low-dose CBD products should let it launch its bestselling CBD product in pharmacies – although it won’t be cheap or quick.
Australia’s Therapeutics Goods Administration yesterday finalised an interim decision from September to downgrade cannabidiol (CBD) oils and pills from Schedule 4 medicine to Schedule 3. This means that they can be obtained directly from a pharmacist, and will no longer require a doctor’s prescription.
In finalising the decision the TGA increased the dose the ruling applies to, saying that pharmacists could dispense products containing up to 150mg of CBD per day, rather than the 60mg a day proposed in the interim decision.
“At 60mg we were going to struggle, as far as proving the efficacy,” Althea chief executive Josh Fegan told Stockhead. “At 150mg, that fits Althea CBD100 perfectly, which is great news.”
Althea CBD100 is a full-spectrum oral oil product that Althea has been selling in Australia under the country’s special access scheme for medicinal cannabis since October 2019.
Like all the products the TGA ruling applies to, Althea CBD100 contains only trace amounts of THC – meaning it won’t get users high.
Fegan said it is used for a range of indications including to treat anxiety, PTSD, insomnia, irritable bowel syndrome and sometimes endometriosis. (It doesn’t have the potency to prevent seizures that higher-dose CBD products do, he said).
But to be sold as Schedule 3 drugs, Althea CBD100 and other products the company has in development will have to be registered in the Australian Register of Therapeutic Goods, meaning Althea will have to provide evidence they work.
Fegan said he’s confident Althea can do that but it will take time.
“If I was an optimist, I’d say less than 12 months,” he said.
The products won’t be inexpensive either. Althea CBD100 sells for around $250 a unit, a price-point that isn’t unusual with legal CBD oil products.
“It’ll get cheaper because of volume,” Fegan said. “It’s obviously much faster consumer turnover in pharmacies.
“This changes the game, because it lowers the bar for patients to get treated. Australians are very used to walk into a pharmacy and talk about a mild condition.
“And it just furthers acceptance of cannabis-based medicine, which is great.”