UK company Chanelle McCoy Health has been granted Ethics Approval to commence a Phase III Efficacy Clinical Trial for the treatment of sleep disturbance using its Ultra Pure Synthetic CBD formulation.
The development will enable the company to begin recruiting for the clinical trial, the results from which should give data on the efficacy of Ultra Pure Synthetic CBD – made with pharmaceutical grade FDA registered raw material – in relation to sleep disturbance and improved sleep.
Chanelle McCoy Health has already invested in its Phase I Safety and Toxicity Pre-Clinical Trials which showed the formulation was well tolerated and there was no sign of adverse behaviour in the dose ranges proposed in the efficacy trial.
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The company has stated that the ethics approval is the next step in achieving an Over-The-Counter (OTC) pharmacy only medicine license.
It can now begin recruiting participants for the trial, registering as a Schedule 3 CBD product for the Australian market, allowing CBD to be sold in pharmacy without a prescription, to improve sleep.
Upon successful completion of this clinical trial, the company aims to launch the product on the Australian Market with ambitions to move into the UK market. There are currently no CBD medicine products sold in pharmacy without a prescription on any global market.
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.”
The CBD formulation (CMH-CBD-001) contains Ultra Pure Synthetic CBD, which is not derived from the cannabis plant so it does not contain pollutants, toxins, terpenes or heavy metals, pesticides, insecticides and no other natural cannabinoid compounds including THC that can occur naturally in the cannabis plant.
