AusCann (ASX:AC8) - CEO, Layton Mills
CEO, Layton Mills
Source: AusCann
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  • AusCann (AC8) submits its final regulatory data modules to the Australian Pesticides and Veterinary Medicines Authority (APVMA) for DermaCann
  • The data in the modules includes findings from a randomised, placebo-controlled study in dogs with atopic dermatitis, which demonstrated a significant reduction in lesions
  • Subject to APVMA approval, DermaCann will become a ‘first in class’ regulatory approved oral cannabinoid-based product for skin health in dogs
  • Completion of the review of all modules is expected at the end of September 2022
  • AusCann is down 1.16 per cent on the market with shares trading at 8.5 cents

AusCann (AC8) has submitted its final regulatory data modules to the Australian Pesticides and Veterinary Medicines Authority (APVMA) for DermaCann.

Founded in 1993, the APVMA is responsible for the management and regulation of agricultural and veterinary chemical products in Australia.

The data in the modules include findings from a randomised, placebo-controlled study in dogs with atopic dermatitis, which demonstrated a significant reduction in lesions.

Data also comes from a randomised controlled target animal safety study which confirmed DermaCann to be safe for use at one, three and five times the planned dose.

Subject to APVMA approval, DermaCann will become a ‘first in class’ regulatory approved oral cannabinoid-based product for skin health in dogs.

If approved, it will also become the first regulatory-approved medicine containing cannabinoids to be available for prescription through vets in Australia.

Completion of the review of all modules is expected at the end of September 2022.

CEO Layton Mills is pleased the final submission has been made.

“Completing our final DermaCann regulatory submissions is the culmination of over three years of hard work and is a pivotal milestone for AusCann,” Mr Mills commented.

“DermaCann is on track to become the world’s first regulatory-approved veterinary medicine containing cannabinoids to be legally available for supply via prescription through veterinarians.”

AusCann has also announced it’s advancing towards US commercialisation with the launch of DermaCann at the industry’s largest global trade show, the VMX conference.

Beginning on January 15, the VMX conference is one of the world’s leading veterinary conferences and is used to promote new animal health products to distributors, animal health partners and veterinarians around the world.

AusCann was down 1.16 per cent on the market, with shares trading at 8.5 cents at 2:45 pm AEDT.

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