Greenfern Industries Limited (GFI) is about to commence the writing of clinical trial protocols for a low dose CBD medication that could set it on the pathway to become a pharmacist-only, over-the-counter product registered in Australia.
In February 2021 the Australian Therapeutics Goods Administration (TGA) made it legal to purchase products containing low-dose (less that 150mg per day) of cannabidiol (CBD) over the counter. This down scheduled the substance from a Schedule 4 (prescription medicine) to a Schedule 3 (S3), pharmacist-only medicine, meaning people with certain ailments could now go to the pharmacist and purchase CBD.
However, S3 products must first be approved by the TGA and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied. This has created a sizable challenge for organisations pursuing S3 registration as applications must be supported by data demonstrating the quality, safety and efficacy of the medicine.
Fresh Leaf Analytics have previously estimated that the pharmacy-only CBD market in Australia will grow to $250 million in product sales at its market maturity and could capture up to 2 million consumers.
GFI managing director Dan Casey said almost 25 per cent of medicinal cannabis patients in Australia take a CBD product at a daily dose below 150mg. It was likely that group may migrate to the pharmacy channel once low-dose CBD products become available over the counter.
“Speed to market is important because the first products to hit the pharmacy-only market will take a considerable market share,” Casey said.
“We’re excited to be continuing on this pathway to get a registered CBD product on the shelves in Australia. We can then look at possible pathways for this product to benefit the patients of New Zealand.”
He said the company had completed a Strategic Assessment Workshop drawing expert advisory from four separate functional areas: trial design, regulations, clinical and commercialisation. This has then led on to a proof-of-concept study design, that proves the concept, including liaising with the TGA and will now begin the protocol writing.
“The protocol will outline how the clinical trial will be run, including the objectives, design, methodology, statistical considerations and organisation of the trial to ensure the safety of participants and the integrity of the data that we would collect,” Casey said.
“This is an exciting opportunity to bring a novel cannabinoid product to the Australian marketplace under the Schedule 3 legislation targeting anxiety. Our novel investigational medical product, GFI-782B, has completed all CMC (chemistry, manufacturing and controls) and toxicology requirements needed for drug registration and is ready to commence first-in-human clinical trials.”
If the trial was to be undertaken and was conclusive it would provide a pathway for the medicine to make its way to approved Australian pharmacies through the Australian Therapeutic Goods Administration’s CBD Schedule 3 and ARTG registration.
GFI has engaged iNGENū, an Australian-based research organisation wholly owned and operated by Cannvalate Pty Ltd, that exclusively focusses on cannabinoid and psychedelic research and whose core focus is quality clinical trials designed for sponsors seeking registration of novel drugs.
iNGENū has extensive experience in Australian based clinical research and their team have established a reputation globally as a specialty contract research organisation.
"The trial design aspects have been calibrated with the team over the past six months and we’re very positive about the outcome of the trial design and the road ahead for GFI."