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.

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.

Combined with a TGA evaluation process of up to six months, the first products are unlikely to be available until late 2022, he told Cannabiz.

With companies eyeing revenue streams beyond prescription medicinal cannabis, the race is now on to be the first to bring products to market.

“The pathway is going to include, typically, proof of concept trials, there’s always going to be a pharmacokinetic requirement and there will be a pivotal trial requirement,” Azzopardi said. “It is a lengthy process where safety, quality and efficacy targets must be met.”

Azzopardi said the MCRC process begins with a Strategic Assessment Workshop – such as that already conducted by Greenfern and now underway with Avecho – where the sponsor’s research idea is “put it through its paces” with a focus on regulatory affairs, trial design, medical affairs and commercialisation.

“This is pulled together in a report so the clients can make up their own mind if that is a pathway for them,” he explained. “The next stage is for us to formulate a TGA package to show that these are our proposed plans to cover all of the elements of safety, efficacy and quality.”

“You might be able to get through the trial pathway in 18 months, and with TGA evaluation taking up to six months, we’re talking around two years for a product to be registered.”

MCRC head julian azzopardi

Once clinical trials are conducted a dossier is then submitted to the TGA which can take up to six months to evaluate, Azzopardi said.

“You might be able to get through the trial pathway in 18 months, and with TGA evaluation taking up to six months, we’re talking around two years for a product to be registered,” he said.

The requirement to demonstrate efficacy for each indication is clearly paramount. In the case of pain that will mean lowering a patient’s Visual Analogue Score, a commonly used measurement of pain, by 33%, according to the MCRC.

But what may not be a precondition of registration is the need to provide safety data, given the TGA’s own report concluded 150mg is a safe dosage.

“Typically, safety is proven with preclinical animal toxicology work but we don’t think that will necessarily be required,” Azzopardi said. “The TGA has come out and said this dosage is safe to be sold over-the-counter without a doctor’s prescription. So we think this could be a moot point.”

Cannabinoid Oil In Laboratory - Medical Cannabis Australia - Cannabiz

While the approximate two-year timeframe may frustrate consumers and companies anxious to drive meaningful revenue, Azzopardi suggested the registration pathway could accelerate over time. With companies exploring similar indications, the TGA could potentially fast track the process once they are satisfied enough data has been collected, he said.

“There will be numerous organisations that might be looking at similar indications, if not the same indications, so at what point will the TGA say, ‘we have that data, efficacy is proven for these indications’?

“I hope they do have some sort of abbreviated process in the future because that will enable more products to become available for consumers and have a positive impact on their lives.”

The decision to down schedule low-dose CBD was widely welcomed by the industry, with several publicly voicing an intention to explore registration pathways and launch products.

But while some may ultimately be deterred by the high cost of clinical trials, Azzopardi predicted many will pursue the vision of over-the-counter medication.

“As a minimum there’s going to be somewhere between one or two handfuls of organisations that will have products in the market,” he suggested. “It will be a competitive industry, and that competition will drive positive, cascading behaviours from a price perspective and force the need to consider different formulations.

“Maybe in the future it will also force the TGA to look at different routes of administration. We’re currently restricted to oral-related administration, but for some conditions and indications there are better routes that could be considered.

“For example, topical administration for someone with eczema or psoriasis is not an option because it’s not approved. Why that is, I’m unsure. Topical systemic absorption is going to be relatively low so if you’re saying it’s safe to ingest it, why on earth wouldn’t it be safe to apply it topically?

“Maybe it’s for companies to challenge that and to make a submission.”

One of the companies working with MCRC, Greenfern Industries, said it was ploughing ahead with the registration pathway.

“We understand the requirements to ensure our patients both now and in the future are receiving a high-quality registered Schedule 3, over-the-counter CBD product, that is proven to be highly efficacious as a treatment for a specific indication,” managing director Dan Casey said. “Therefore, we have committed to the creation of a registered novel cannabinoid drug utilising the MCRC.

“Having already undertaken a Strategic Assessment Workshop with MCRC and with our unique novel formulations already under development, Greenfern is well equipped for a clear pathway to success.”

Paul Gavin: conducting a strategic assessment

Meanwhile, Avecho chief executive Paul Gavin confirmed it was exploring the development of an S3 product.

“Avecho is excited to be working with the CRO, Medicinal Cannabis Research Collaboration (MCRC),” he said. “We are currently conducting a Strategic Assessment Workshop to investigate the optimal medical indication to register our enhanced CBD product with increased bioavailability as a Schedule 3 over-the-counter CBD product.”

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