Oz Medicann Group (OMG) is conducting a trans-Tasman clinical trial of its CBD sleep formula with a view to Schedule 3, over-the-counter registration.
NICM Health Research Institute Emeritus Professor Alan Bensoussan will oversee the study, along with sleep expert and Wink CEO Professor Mike Gradisar.
The team will run the Phase IIB/III clinical trial using OMG’s CBD formulation for insomnia across sites in Australia and New Zealand. Expected to start in June, it will run for eight weeks with more than 300 adults taking part.
OMG founder and CEO John Leith said: “We believe our higher dosage solution, unique formula and delivery technology will deliver the best outcomes for sleep-deprived adults. It’s a gamechanger for those suffering [from] sleep deprivation.”
He said the growing market for plant-based medicine, the rise in sleep disorder diagnoses as a result of Covid-19, and limited access to medicinal cannabis, make it “fertile ground to launch our new product”.
“Successful completion of the trial will provide us with unprecedented commercial opportunities in a rapidly growing market,” he added.