UK firm Chanelle McCoy Health (CMH) has been granted ethics approval for a Phase III trial of its ultra-pure synthetic CBD formulation for the treatment of sleep disturbance.
The trial is the latest stage in the company's bid to register an over-the-counter (Schedule 3) CBD sleep medicine in Australia, with further ambitions to move into the European market and beyond.
CMH has already successfully completed a Phase I safety and toxicity pre-clinical trial which showed its CMH-CBD-001 formulation was well tolerated with no adverse effects in the dose ranges proposed in the efficacy trial.
Having received approval from Bellberry Human Research Ethics Committee, the company can now begin recruiting for the trial.
Co-founder and chief science officer Caroline Glynn said: "The beginning of this trial is incredibly significant for Chanelle McCoy Health as a company, but also in driving the data surrounding ultra-pure synthetic CBD.
"Registering our product as an OTC medicine will allow us to finally address the demands of many people who suffer from insomnia or sleep disturbance."