UK company, Chanelle McCoy Health, has been granted ethics approval in Australia for a clinical trial investigating the effect of its synthetic CBD formulation on sleep.
The pharmaceutical company has received Ethics Approval from Bellberry Human Research Ethics Committee in Australia, for a significant Phase III Efficacy Clinical Trial for the treatment of Sleep Disturbance.
The results of the clinical trial should give key data on the efficacy of the company’s unique formulation, Ultra Pure Synthetic CBD in relation to sleep disturbance and improved sleep.
This CBD formulation (CMH-CBD-001) has the highest quality of pharmaceutical grade raw material being FDA Registered with a Drug Master File.
The company has already successfully completed Phase I Safety and Toxicity Preclinical Trials which revealed its Ultra Pure Synthetic CBD was well tolerated and there was no sign of adverse behaviour in the dose ranges proposed in the efficacy trial.
Successful completion of the Phase III Efficacy Clinical Trial, coupled with the existing scientific data, will support the company’s registration as a pharmacy-only medicine product with Australian health authorities, Therapeutic Goods Administration (TGA).
This would enable pharmacists to supply Chanelle McCoy Health’s Ultra Pure CBD (CMH-CBD-001) product to Australian patients without a prescription for the treatment of sleep disturbance and improve sleep.
This latest milestone will enable the company to begin recruiting for the clinical trial.
Synthetic CBD
The company, which was founded by Lady Chanelle McCoy and Caroline Glynn, is also behind the UK CBD brand Pureis, for which Mike Tindall MBE is an ambassador.
CMH-CBD-001 product contains Ultra Pure Synthetic CBD, which is not derived from the cannabis plant. This means there is no trace of pollutants, toxins, terpenes, heavy metals, pesticides, insecticides or other cannabinoid compounds that can occur naturally in the cannabis plant.
There is also minimal water usage and no intra batch variability, or concern about crop failure and reliance on weather or soil conditions which affects yield of plant grown sources.
Lady McCoy and Ms Glynn have over two decades of experience in the pharmaceutical industry, having registered over 2,500 medical licences across 96 countries.
Their mission was to bring a pure, safe, quality assured CBD product that was backed by clinical studies.
Founder and CSO, Caroline Glynn B.Sc., MSc., L.LM, commented: “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.
“We are beginning the process of recruiting for our clinical trial. 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. This is the first of many Phase III Efficacy Clinical Studies in our R&D Strategic Plan using our Ultra Pure Synthetic CBD.”
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