Western-Australia based medical cannabis company AusCann Group Holdings (ASX: AC8) has announced that it is beginning the process of seeking registration approval for its DermaCann CBD medication.
In an ASX release published on the 20th of July, the company revealed that it has submitted its first module to the Australian Pesticides and Veterinary Medicines Association (APVMA). In total, the company will need to submit four modules and prove that DermaCann satisfies APVMA’s safety, trade and efficacy criteria.
If these criteria are met, DermaCann will become Australia’s first CBD-containing medication prescribed to dogs. DermaCann is an oral medication that would need to be prescribed by a veterinarian. It is an anti-inflammatory drug that provides “immune support” to dogs with dermatological conditions. Currently, approximately 1 million Australian dogs suffer from dermatological conditions.
This first module AusCann submitted to APVMA contains DermaCann’s Safety and Toxicological evaluation. The evaluation contains 2,000 pages of data, and took three years and eight independent in-vivo (animal) and in-vitro (test-tube) studies to complete. It also outlines the results of a study AusCann conducted on dogs last year. In the study, the dogs that were given DermaCann showed significant improvement with their skin conditions and reduced their treatment by an average of 51%.
According to AusCann’s Safety and Toxicology Advisor Dr Jeffery Sherman, it’s been “very exciting” to work on Australia’s first CBD veterinary product.
Now that the required safety studies and toxicological evaluation has been conducted, we can give greater certainty to veterinarians that this CBD medicine will be safe for use in dogs.
AusCann expects the APVMA’s approval process to take 18 months to complete. It believes it will register DermaCann in Q4, 2022. The worldwide canine skin and dermatitis market is worth around $US1.5 billion.
The company has already taken steps to bring DermaCann to market in other countries. In South Africa, the company has submitted approval documents to the South African Department of Agriculture, Forestry and Fisheries. Soon, it intends to do the same with the Agricultural Compounds and Veterinary Medicines (ACVM) in New Zealand. AusCann has also “progressed preparations” to commercialise DermaCann in the US, where it won’t need registration in some states that have legalised cannabis.