ASX-listed healthcare technology company Lifespot Health is planning to conduct extensive clinical trials in 2021 to meet the TGA safety and efficacy standards required for medical registration of its combined medical inhaler/cannabinoid e-liquid products.
Lifespot Health CEO Matthew Golden said he expects the trials will demonstrate greater cost effectiveness for patients and could lead to CBD vapes being available over the counter at pharmacies in the foreseeable future.
In its interim decision on the down-scheduling of CBD announced in September, the TGA specifically excluded vapes from Schedule 3, while limiting the maximum dose of oral ingestibles to 60mg per day in a move which left many in the industry fearing they would be unable to prove efficacy at that level.
While the former makes life more difficult for Golden, he is unphased by the latter due to the lower doses at which he said vaping is effective.
“A lot of people are concerned that the daily dose is a little low to show any real therapeutic effect for an edible, but we believe we can get efficacy through vaping at that level,” he said.
“If an oral ingestible needs 60mg of active CBD to have an effect, it’s going to lose 90-95% of that dose to 1st pass metabolism, so only maybe 3-6 mg is going to make it into the bloodstream and to the receptor site.
“However, if the same 60mg dose is delivered via a vape inhaler, then approximately 55-60% of the dose will pass directly to the bloodstream resulting in 33-36 mg making it to the receptor site, which is far more likely to have a therapeutic effect for the patient.”
Golden said its fast-acting nature means vaping is a particularly cost-effective medicinal cannabis delivery mechanism for patients needing immediate relief from pain, anxiety, panic attacks and insomnia.
However, he acknowledged there are two hurdles to jump before it can command a significant slice of the medicinal cannabis market in Australia – a lack of clinical evidence to put before the TGA and the stigma associated with vaping caused by illicit players in the cannabis vaping market.
“The issue would be to show the TGA enough safety data to prove vaping is okay,” he said. “There’s probably a little bit of stigma too, but the data will help with that.”
Golden said part of the early clinical trial program will look at dose tolerability and optimal dosing before side effects kick in, but he is confident the results will show vaping to be fast, effective and safe at low doses.
“Certainly from a Schedule 3 point of view, at 60mg a day a vape is going to be far more likely to show a therapeutic effect than an oral ingestible,” he added.
Golden said the company aims to start clinical trials early next year, and will be working with the TGA to determine the length and scope required for registration. However, he said product could be available as early as Q1 or Q2 2021 via the Special Access Scheme.
He added the trials will focus on vaping cannabis e-liquids rather than flower, as it is easier to control dosing and quality.
The other challenge facing vaping companies is the negative publicity that hit the cannabis vape market in 2019 after an outbreak of severe lung disease in the US that the Centers for Disease Control and Prevention (CDC) linked to cannabis vaping liquids cut with vitamin E acetate.
Golden said the outbreak was evidence that regulation is needed.
“What happened in the US was unacceptable, but it was a result of pushing things on to the black market and refusing to legalise and regulate. It was black market operators adding acetate.
“No-one likes regulation in any industry, but with cannabis it will help legitimize it, set safety standards and secure supply chains to deliver safe products to patients.”
In Canada, cannabis vaping reached 16% market share within six months of becoming available. Golden said if vapes achieve 10% of the Australian market by 2024 that would equate to almost A$178 million in sales.