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- Avecho Biotechnology (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
- The meeting will look at Avecho’s planned clinical program to support product registration as a schedule 3, pharmacist-only medicine in Australia
- While Avecho says its gel has the potential to treat a number indications, the focus will fall on insomnia for the basis for the initial indication
- AVE’s product falls within the TGA’s approved dosage of products, containing 75 milligrams of CBD per capsule, allowing for efficient dosing within Australian guidelines
- Avecho’s complete product development strategy will be refined after the TGA pre-submission meeting later this year
- Avecho Biotechnology is up 6.67 per cent, trading at 1.6 cents
Avecho Biotechnology (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.
The meeting will look at Avecho’s planned clinical program to support product registration as a schedule 3, pharmacist-only medicine in Australia. It will address specific design aspects of a phase three study, together with its safety information.
This follows the TGA’s decision to allow the sale of registered pure CBD products by pharmacists in December 2020.
Avecho’s product falls within the TGA’s approved dosage of products, containing 75 milligrams of CBD per capsule, allowing for efficient dosing within Australian guidelines. The product also contains AVE’s patented Targeted Penetration Matrix (TPM), which has been shown to increase the oral bioavailability of CBD.
Whilst Avecho says its CBD soft-gel has the potential to treat a number indications, the focus will fall on insomnia for the basis for the initial indication.
The company says clinical trials have previously demonstrated CBD can increase sleep duration when compared against a placebo, plus reduce the time it takes to fall asleep. That said, some of these results were obtained using CBD doses above 150 milligrams, potentially biasing success in this indication toward products with increased bioavailability.
The Australian market for insomnia related products is currently around $250 million, incorporating a mixture of prescription, non-prescription and complementary medicines.
Avecho has engaged the services of Cannvalate, a premier contract research organisation specialising in the clinical development of medicinal cannabis products, for its TGA pre-submission.
Avecho’s complete product development strategy will be refined after the TGA pre-submission meeting later in the year.
Avecho Biotechnology is up 6.67 per cent, trading at 1.6 cents at 1:00 pm AEST.