Several companies have begun exploring trial pathways with Cannvalate’s clinical research arm as they seek to bring Schedule 3 over-the-counter products to Australian consumers.

The Medicinal Cannabis Research Collaboration (MCRC), a joint venture between Cannvalate and a major Melbourne university, said it is supporting five firms in their respective bids to register low-dose CBD medicine with the Therapeutic Goods Administration, including ASX-listed Avecho and New Zealand-based Greenfern Industries.

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Julian Azzopardi: two years (from December 2020) before a product hits the shelves

The identities of the other three companies have not been disclosed.

Avecho is currently conducting a Strategic Assessment Workshop – the first stage in the MCRC process – while Greenfern said its formulations are already under development.

Additionally, Cannvalate chief growth officer and head of MCRC, Julian Azzopardi, revealed that two trials specifically geared around low-dose CBD are underway for the treatment of insomnia and muscle inflammation.

The clamour to demonstrate efficacy for low-dose CBD follows the TGA’s decision in December to allow a maximum daily dose of 150mg to be sold at pharmacies without a prescription from February 1.

It triggered a surge of interest from consumers who, stoked by an excitable mainstream media and positive industry chatter, reportedly flocked to pharmacies expecting – wrongly – to find product available from that date.

Media coverage and some excitable industry reaction created the impression that CBD would be available from February 1

But Azzopardi stressed the pathway to listing an S3 medicine on the Australian Register of Therapeutic Goods (ARTG) – a prerequisite for any company wishing to sell CBD over the counter as a pharmacy-only medicine – will be a detailed process requiring up to 18 months’ work.

Steve has reported for a number of consumer and B2B titles over a journalism career spanning more than three decades. He is a regulator contributor to health journal, The Medical Republic, writing on...