Oxycodone

About Oxycodone

Oxycodone, a leading pain management drug, is currently administered in tablet or intravenous form and is more potent than morphine with fewer adverse effects.  In 2007, global sales of oxycodone exceeded $2679m USD.

Phosphagenics 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 technology can effectively deliver opiates through the skin without causing any disruption or irritation. 

Phase 1B Study

Phosphagenics conducted two phase I studies in 2009 on its TPM/oxycodone formulation, both with successful results.   The first study, an open-label, human Repeat Insult Patch Test (RIPT) evaluated the skin response of fifty healthy participants with both an induction phase and a challenge phase.   The study concluded that no significant erythema or sensitization were observed. 

The second study, a Repeat Dose Application study, was an open label, single centre pharmacokinetic study in twenty healthy volunteers conducted at the Royal Adelaide Hospital.   Its primary objective was to compare the delivery profiles of two transdermal patch candidates containing TPM™, a matrix and a reservoir system, following daily application over a ten-day period.   The study reported positive results using the Company’s proprietary TPM™ (Targeted Penetration Matrix) technology for the transdermal delivery of oxycodone and revealed that daily application of the TPM/oxycodone patch delivered therapeutic bloodstream levels in a reproducible, consistent and sustained manner, again with no irritation observed.

Phosphagenics is now planning the next stage of its oxycodone development. Under the guidance of Professor Guy Ludbrook, Head of Discipline, Anaesthesia & Intensive Care, at the Royal Adelaide Hospital, Phosphagenics has assembled an advisory panel of international pain experts to plan the path forward into its Phase 2/3 trials and beyond.    Phosphagenics expects to commence its next clinical study in the second half of 2010.

TPM/oxycodone Fact Sheet