Phosphagenics Announces Successful Phase 1 Transdermal Oxycodone Clinical Trial Results
Phosphagenics announced positive results of its Phase 1 clinical trial that showed its delivery technology, TPM, delivered leading pain-relief drug oxycodone through the skin without causing disruption or irritation of any kind.
These results support Phosphagenics' aims to be the first company to commercialize a sustained release oxycodone patch for the management of chronic pain.
"Oxycodone, with worldwide annual sales of more than $1 billion, is more potent than morphine with fewer adverse effects; however, oxycodone is not available transdermally due to serious issues relating to skin sensitization and irritation," said Dr. Esra Ogru, Executive Vice Presidentof Research and Development at Phosphagenics. "Our trial results show that TPM can deliver oxycodone through the skin in a sustained release formulation without causing skin irritation."
This trial, which was conducted by CMAX (an independent clinical research organization located at the Royal Adelaide Hospital) was a single-centre, single-blinded, pharmacokinetic trial in 16 healthy subjects. The trial endpoints were to evaluate the safety and tolerability of the TPM/Oxycodone formulation and the ability of the TPM technology to deliver oxycodone into the body.
The oxycodone, administered as a single transdermal application, was safe with no adverse events reported. Oxycodone was detected in the subjects for at least 48 hours. The results demonstrate that the formulation is bioavailable and effective in delivering oxycodone into the body.
A collaborative program is now under way with a world leading patch development company to incorporate the current formulation into a patch system. Plans are also underway to undertake a pivotal clinical study in the first half of 2008.
"Developing our pain relief pipeline builds on the success of Phosphagenics' previous transdermal clinical trials and provides a platform for the development of many other products," added Dr. Ogru.
Mr. Harry Rosen, President and CEO of Phosphagenics, said: "Completing this Phase 1 trial was an important milestone for our pain management program. We are delighted to have successfully completed this trial and look forward to progressing to the next phase."