Phosphagenics Limited (“Phosphagenics”) (ASX: POH, AIM: PSG, OTCQX: PPGNY) today 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 any disruption or irritation.

Dr Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said these results support Phosphagenics’ aims to be the first to commercialise a sustained-release oxycodone patch for the management of chronic pain.

“Oxycodone, with worldwide annual sales of more than $US 1 billion, is more potent than morphine with fewer adverse effects; however, oxycodone is not available transdermally due to serious issues relating to skin sensitisation and irritation,” Dr Ogru said.

“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 organisation 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.

Dr Esra Ogru said that developing its pain relief pipeline builds on the success of previous transdermal clinical trials and provides a platform for the development of many other products.

Mr Harry Rosen, President and CEO 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”.

ENDS…. 

APPENDIX AND NOTES TO EDITORS

About the trial

Objectives:

The primary objective was to evaluate the tolerability and safety of a single 200mg dose of oxycodone formulated with the TPM delivery technology (TPM/Oxycodone) applied transdermally. The secondary objective was to assess the pharmacokinetics of TPM/Oxycodone.

Trial Design:     

The trial was a single centred, single blinded, placebo-controlled trial which assessed TPM/Oxycodone in 16 healthy subjects.

Trial Duration:

5 days

Results:

The primary endpoint of safety and tolerability was met as there were no unexpected adverse events. The detection of oxycodone in the urine of subjects demonstrated that the TPM formulation is bioavailable and effective in delivering oxycodone into the body.