Avecho Biotechnology Limited (ASX:AVE) is proceeding to a pre-submission meeting with the Therapeutic Goods Administration (TGA) to present plans for the development and registration of its pharmaceutical cannabidiol (CBD) soft-gel product: its first target being for an insomnia related indication.
The meeting will examine the proposed indication and appropriateness of Avecho’s planned clinical program to support product registration as a Schedule 3 (S3) pharmacist only medicine in Australia. It will address specific design aspects of a pivotal phase III study, together with the available safety information related to the cannabidiol and the specific soft-gel product.
The TGA announced its decision to allow the sale of registered pure CBD products by pharmacists in December last year. Potential S3 registration is now limited to oral, oral mucosal or sublingual products with a maximal daily dose of 150 mg that are packaged securely in child-proof containers. Avecho’s soft-gel product contains 75 mg per capsule, allowing for efficient once or twice per day dosing within the TGA’s established dosing guidelines. Avecho’s soft-gel product also contains TPM, which was shown to increase the oral bioavailability of CBD.
CEO, Dr Paul Gavin, said, Avecho has engaged the services of Cannvalate for the TGA pre-submission. Cannvalate has developed the Medicinal Cannabis Research Collaboration as a premier Contract Research Organisation specialising in the clinical development of medicinal cannabis products. Cannvalate has already participated in TGA-presubmission applications for other medicinal cannabis companies, and is uniquely placed to help Avecho in optimising engagement with the TGA.
We are committed to working closely and constructively with the TGA and other key regulators as we develop our clinical trial programme and products, to ensure our company is primed to register our CBD soft-gel product in key markets,” Dr Gavin said.
“We have engaged the Cannvalate team to run the TGA pre-submission meeting, due to their extensive experience in the Australian medicinal cannabis space wih an emphasis on TGA interactions.”
Dr Gavin said whilst Avecho’s CBD soft-gel has the potential to treat a number of candidate indications, the company has determined that insomnia should be the basis for the initial indication.
He said clinical trial data has demonstrated that CBD can increase sleep duration when compared against placebo, in addition to reducing the time it takes to fall asleep. Some of these results were obtained using CBD doses above 150 mg, potentially biasing success in this indication toward products with increased bioavailability.
