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.