Phosphagenics To Conduct Phase 1 Transdermal Oxycodone Clinical Trial
Transdermal Oxycodone Clinical Trial
Phosphagenics Limited plans to undertake a Phase 1 transdermal oxycodone clinical trial aimed at providing chronic pain sufferers with a sustained-release pain management product.
Phosphagenics has submitted all necessary documents for approval of the trial, which is to be conducted at CMAX - an independent clinical research organization located at the Royal Adelaide Hospital. The trial, which will be in up to 30 healthy volunteers, will evaluate the tolerability and safety of the novel transdermal oxycodone. The trial will begin once approval has been received, which is expected within the next six weeks.
The Company is working towards becoming the first to provide chronic pain sufferers with a patch that will provide sustained-release of oxycodone into the bloodstream. Previous clinical trials have demonstrated that Phosphagenics' patented technologies can effectively deliver opiates through the skin without causing any disruption or irritation.
Harry Rosen, Phosphagenics' President and CEO, said: "We have prioritized oxycodone over morphine in our pain management pipeline as we are in commercial discussions with several companies.
"These companies' commercial interests are focused on the license of a transdermal pain product containing oxycodone."
Dr. Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said: "Our objective is to address a large unmet need by using our technology to deliver oxycodone in a sustained-release formulation to treat pain beyond a 24 hour period."
Oxycodone, currently administered in tablet or intravenous form, in an eight to 12 hour formulation, is more potent than morphine with fewer adverse effects and its worldwide sales exceed $1 billion annually.