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news.Phosphagenics has reported positive results from a Phase I 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.
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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 demonstrated that the formulation is bioavailable and effective in delivering oxycodone into the body.
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.
A collaborative program is now under way with a patch development company to incorporate the current formulation into a patch system. The company plans to undertake a pivotal clinical study in the first half of 2008.
Harry Rosen, president and CEO of Phosphagenics, said: “Completing this Phase I trial was an important milestone for our pain management program.”