The ASX-listed company will make its debut in Australia’s schedule 3 CBD market with a soft-gel capsule for addressing insomnia.
A schedule 3 CBD product for oral, oromuscosal, or sublingual use could be sold over the counter via pharmacists’ recommendation – a new policy which Australia’s Therapeutic Goods Administration (TGA) has put in place since Feb 1 last year.
The move will open more opportunities for CBD use for therapeutic purposes. Prior to the implementation of this policy, oral CBD products are only available via doctors’ prescription.
Bod Australia is one of the companies which has started preparing for schedule 3 CBD market entry.
It recently enrolled participants for its phase IIB double-blind, randomised, and placebo-controlled trial, where the effects of its CBD formula on insomnia will be tested.
Evidence from the 8-week trial involving 200 participants would be submitted for the firm’s CBD product to be registered into the Australian Register of Therapeutic Goods (ARTG). The products need to be included in the ARTG before they could be legally supplied in Australia.
Speaking to NutraIngredients-Asia, CEO Jo Patterson said timing would be the biggest challenge in navigating the entire process.
“The challenge from my perspective is really just timing, how long things take, you know, it is a lengthy process.
“But I’m really confident with the clinical trial design. I'm very confident with the partners that we've selected. We're working with the Woodcock Institute and so they are the study site.
“We are really excited about the trial and the efficacy that we hope to prove with the products. Also, I think that importantly, it is a very significant need amongst consumers, adults, patients and I think that to have a non-pharmacological solution into the Australian market that treats insomnia and sleeplessness is really exciting,” she said.
For the clinical trial, the participants will be randomised into three groups, taking either a 50mg CBD, or 100mg CBD soft-gel capsule or a placebo.
Patterson said the trial was expected to be completed by the end of this year and the data for dossier submission next year.
“Each of those patients are on the trial for eight weeks. But the duration of qualification and finishing is approximately 12 weeks.
“There's 200 patients in the trial, so we expect to be finished sometime at the end of this year, and then we will analyse that data, prepare the dossier and submit it early 2023 to the TGA.
“The TGA offer a standard guide of approximately 200 days that they will take to review and approve the dossier and its findings which will lead to an ARTG registration.
“We certainly are hopeful that it might be more efficient than that. But you know, that is an element that we can't control.”
NutraIngredients-Asia understands that the TGA has not yet approved any low dose schedule 3 CBD products for supply in Australia as of May 11.
Prior to inclusion in the ARTG, the products will be individually evaluated for safety, efficacy, and quality.
So far, the TGA has held meetings with a range of companies on the registration process, clinical trial design and evidence requirements.
Retail market worth
According to a survey conducted by a third-party, Patterson said that retailers’ interest in schedule 3 CBD products could hit 190,000 units and retail sales of AUD$16m (US$11m).
The survey was conducted to understand pharmacies’ interest and demand for schedule 3 CBD products.
“What we then did is we look at what the value of CBD currently used per millilitre of the same sort of product that we would be developing.
“And so, we looked at CBD per millilitre and what they're currently being charged to patients in the Australian market. If we calculate that out on 190,000 units, it represents approximately AUD$14 to 16 million in retail sales,” Patterson said.
In terms of the amount of investment, she said that the funds used in the clinical trial was “a material amount of money that one would expect is invested in a normal pharmaceutical trial”.
Aside from Australia, there are plans to bring the product into the US through a FDA registration, as well as into Europe.
The global insomnia market is expected to reach US$6.38bn by 2030, according to data from Allied Market Research.
“It's certainly a significant need where there is little or no alternative that offer a non-pharmacological solution, so we're really excited about a low dose CBD to treat this need state,” Patterson said.