AusCann Group’s (ASX: AC8) hard shell medicinal cannabis products are now available for prescription Australia-wide, with clinical trials also ready to kick-off into evaluating different doses of its THC-CBD formulations.
In parallel with the upcoming clinical study, AusCann has made its medicinal cannabis capsules available to Australian patients via the Therapeutic Goods Administration Special Access Scheme.
As part of this, AusCann has shipped the hard-shell capsules to its distribution partner CH2, with authorisation now granted for prescription sales across the country.
“AusCann has developed standardised cannabinoid-based formulations in a dose-controlled capsule,” AusCann chief executive officer Ido Kanyon said.
“The capsules have been tested in a lab setting and demonstrated to be reliable, stable and deliver a consistent controlled dose of the formulations.”
He added the company was now excited to begin clinical evaluation of the capsules to demonstrate their benefits.
Making the hard-shell capsules commercially available now is ahead of the company’s previously outlined deadline of targeting distribution before mid-year.
Clinical trial for CBD-THC medicinal cannabis capsules
The clinical trial will be held at independent clinical site Nucleus Network and will evaluate the pharmacokinetics of its hard-shell capsules at different dose strengths of the CBD-THC formulations.
AusCann anticipates the trial will provide key exposure information to assist with appropriate dose selection.
Nucleus Network plans to begin recruiting for the trial next month.
However, AusCann did note developments surrounding the COVID-19 pandemic would need to be monitored and study timelines may be adjusted accordingly if required.
Despite this, Mr Kanyon pointed out clinical evidence will be derived from patients who procure the capsules via the Special Access Scheme.
According to AusCann, its hard-shell capsules are a “unique presentation” for cannabinoid medicines.
“This is an exciting time for AusCann as we establish the company as a trusted pharmaceutical player with a reliable, stable and standardised product,” Mr Kanyon said.