Australia’s Bod Science Limited (ASX:BOD) has completed its phase IIB clinical trial for a potential Schedule 3 cannabidiol (CBD) product. But for the results, we’ll need to wait a little longer.
Carried out in partnership with sleep research organization the Woolcock Institute of Medical Research, the trial assessed the efficacy of Bod’s CBD formulation in a double-blind, randomized, and placebo-controlled environment.
198 participants suffering from insomnia symptoms were administered either 50mg or 100mg oral doses of Bod’s proprietary CBD product or a placebo daily over an eight-week period. With the ‘last patient, last visit’ milestone reached early this month, Bod is eagerly awaiting the trial outcomes.
Assuming those are favourable, Bod intends to submit results to Australia’s Therapeutic Goods Administration (TGA) for review in the final quarter of this year. If the TGA gives the thumbs-up, this could potentially be the first Schedule 3 CBD product available in Australia.
Several companies are racing to be the first or among the first to get the coveted Schedule 3 (S3) status for low-dose cannabidiol medications in Australia. Products classified S3 are “Pharmacist Only”, meaning a prescription isn’t necessary – but counselling and verification by a pharmacist is required before supplying a patient.
In late 2020, the TGA gave the green light to down-scheduling low-dose CBD, and medicines could have been available from February 2021. But more than two years later, such over-the-counter products are yet to appear on pharmacist’s shelves as the approval process is a long (and expensive) one.
“We’re thrilled to have reached this important milestone in delivering our uniquely developed Schedule 3 CBD formulation,” said Bod Science CEO Jo Patterson. “The now completed clinical trial is the only advanced Schedule 3 CBD product
candidate for the Australian market.”
Ms. Patterson also expressed her gratitude to the patients and research partners involved in the trial.
“A huge thank you to all our patients for volunteering to be part of the trial. Thanks also to our hardworking research partners at the Woolcock Institute of Medical Research. We look forward to receiving the results of the study next month.”
In January this year, another Australian medical cannabis company was dealt a blow in relation to a S3 CBD candidate also targeting sleep-related conditions. Cann Group’s CBD preparation did not demonstrate a statistically superior response compared to placebo for treating sleep disturbance.
