The trial will use a new, custom CBD formulation developed in Switzerland by Australian firm Bod Australia, which plans to commercialise the formulation in its home and export markets.
While medicinal CBD products are available through prescription for some conditions in Australia, supplements containing CBD are not permitted to be sold over-the-counter at pharmacies, supermarkets or other retail outlets.
CBD products are considered Schedule 4 substances, which refers to prescription-only medicines. Due to its THC content, however, Bod's new formulation falls under Schedule 8, which covers controlled drugs and is considered the country's most restricted classification for medicines and other health products.
In the UK and Europe, however, Bod's CBD supplements have been doing well.
Its NutraCabilis range consists of soft-gel capsules in bottles of 60, with six different applications: a general CBD supplement, a 'pure' supplement to support overall health, and one each to relieve stress, aid in sleep, reduce nausea during travel, and relieve pain.
Bod has said the next phase for NutraCabilis would be beverages, followed by a third phase involving sublingual wafers.
It also has an oral medication, MediCabilis, which consists of a CBD extract within MCT (medium-chain triglyceride) oil, and is classified as a controlled, prescription-only drug.
The company is targeting the US and Belgium, and signed a deal last month with Belgian natural medicine manufacturer Tilman to distribute both NutraCabilis and MediCabilis in pharmacies and specialty retailers in Belgium and Luxembourg.
Chief scientific officer Adele Hosseini told NutraIngredients-Asia that while the focus for the new formula in Australia is as a medicine for Tourette's patients, other markets could present less restrictive opportunities.
"In our other markets such as Germany and Switzerland, if the market demands it and the law permits it, we don't have any reservations about selling over-the-counter supplements using this formulation.
"Right now, we have not planned anything concrete in this regard, but we are definitely open to the idea.
"We are also quite interested in expanding to other APAC countries, like South Korea and the Philippines. We don't have any contacts there right now, but ultimately, our goal is to expand further in the region."
Bod's cannabis business has been doing well, as it reported a record US$872,240 (A$1.22m) revenue for Q4 2018 amid its growing CBD business, which has been managed chiefly by executive chairman George Livery.
The firm expects the new product to generate sales in Australia, and is pursuing commercial opportunities that include product development and licensing.
Tourette's on trial
Conducted in Brisbane by Wesley Medical Research in partnership with the University of Sydney, the current trial involves the custom formulation, and is funded by the university's Lambert Initiative for Cannabinoid Therapeutics.
Recruitment for the doubled-blinded, placebo-controlled crossover trial, led by chief investigator and neuro-psychiatrist Dr Philip Mosley, began in mid-March for a total of 28 participants above the age of 18.
Patients will be given either a placebo or the medical cannabis product for six weeks, followed by a four-week washout period, then another six weeks whereby the patients who have taken the placebo will switch to the medical cannabis product and vice versa.
Clinical research fellow at the Lambert Initiative, Melissa Benson, told NutraIngredients-Asia: "We approached Bod Australia (to provide the CBD formulation) and based on our requests and the scientific premise of what was most appropriate for the trial and its participants, they created a custom pharmaceutical-grade cannabis extract with a 1:1 ratio of THC to CBD."
Tetrahydrocannabinol or THC is cannabis' main psychoactive component, while cannabidiol or CBD is a phytocannabinoid that accounts for up to 40% of any cannabis plant extract.
Benson added: "The primary objective of the study is to use a clinical measure of tics to see if medical cannabis can reduce the total tic score and severity in patients when compared to those on placebo."
"It focuses on a clinical outcome instead of one revolving around safety and tolerance, but those are still secondary considerations."
The trial will also assess the cognitive and psychiatric symptoms linked to Tourette’s and whether medical cannabis has any effect on them.
Pros for patients
The neurological disorder known as Tourette syndrome begins developing in childhood, with involuntary movements and vocalisations — more commonly called tics — the most recognisable symptoms. The more frequent and severe the tics, the less likely a sufferer is able to function regularly and perform day-to-day tasks.
There is no known cure for the condition, though doctors typically prescribe medication to help control tics. Unfortunately, this often results in negative side effects, such as depression, sleepiness, and weight gain.
However, the current study may significantly improve patients' prospects. According to Lambert Initiative academic director Prof Iain McGregor, evidence from previous studies already support the use of medical cannabis to treat Tourette's.
Benson said, "The existing evidence so far has been good. Already, some Tourette's patients in Australia have been prescribed CBD through the SAS (Special Access Scheme), and they've reported positive effects.
"This study was several years in the making, because it was delayed by drug availability problems. But now, it will build on existing evidence in a crossover, placebo-controlled manner."
CEO Jo Patterson said, "Collaborating and supplying an organisation of the Lambert Initiative's calibre is significant validation of Bod's product superiority and global uniqueness, as well as the company's growing presence in the medicinal cannabis space.
"To have our extracts utilised in an external clinical trial investigating the effects of medicinal cannabis in relation to Tourette syndrome positions Bod exceptionally well for the future. Pending any successful results in relation to this specific condition, Bod will ensure the formulations are made available to eligible patients and approved prescribers under the SAS Category B.
She added that the firm was looking forward "any ongoing collaborations with the Lambert Initiative", and would "continue to support them with our unique cannabis extracts for their trials".