Sustained release for pain relief

Source: Phosphagenics

Melbourne biotech Phosphagenics has released positive results of a Phase 1 human trial of its sustained-release oxycodone patch for the management of chronic pain.

Dr Esra Ogru, executive vice president of research and development at Phosphagenics, said the results showed that Phosphagenics' delivery technology, TPM, delivered leading pain-relief drug oxycodone through the skin without causing any disruption or irritation.

"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 in a gel or patch administration due to serious issues relating to skin sensitisation and irritation," Ogru sid.

"Our trial results show that TPM can deliver oxycodone through the skin in a sustained-release formulation without causing skin irritation.

"These results further validate the broad application of our TPM technology and its ability to deliver compounds, such as insulin and morphine, through the skin without causing any disruption or irritation to the skin."

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. 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 gel 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.