Positive results from Phase 1B study of Phosphagenics' transdermal oxycodone patch

03-Feb-2010 - Australia

Phosphagenics Limited announced positive results from a Phase 1B clinical study using the Company’s patented TPM™ (Targeted Penetration Matrix) for the transdermal delivery of oxycodone. This successful trial showed that daily application of a TPM™-oxycodone patch delivered therapeutic bloodstream levels of oxycodone in a reproducible, consistent and sustained manner.

“The ability to reach therapeutic oxycodone plasma concentrations from a transdermal patch is a major achievement, and the sustained blood levels of this drug appear very suitable for chronic pain management,” said Professor Guy Ludbrook, Principal Investigator for the study and Head of Discipline, Anaesthesia & Intensive Care, at the Royal Adelaide Hospital. “After a dose of oral oxycodone pain relief is provided for only a matter of hours. The use of Phosphagenics’ oxycodone patch may provide sustained drug delivery for a matter of days, thus removing some of the peaks and troughs of pain relief associated with oral treatment.”

The open label, single centre pharmacokinetic study in 20 healthy volunteers was conducted at the Royal Adelaide Hospital. The primary objective of the study was to compare the delivery profiles of two transdermal patch candidates containing TPM™, a matrix and reservoir system, following daily application over a ten-day period. Plasma oxycodone concentrations were monitored throughout the study to assess which of the two patch systems produced the best delivery profile.

Results from the study demonstrate that oxycodone plasma concentration increased throughout the entire ten day dosing period after daily application of the matrix patch. Average plasma concentrations reached therapeutic levels and continued to rise daily during the ten day study. Rapid drug elimination was also evident immediately after the removal of the final matrix patch on the tenth study day.

As a consequence of this clinical trial, Phosphagenics is planning the next stage of its oxycodone development. Under the guidance of Professor Guy Ludbrook, Phosphagenics has assembled an advisory panel of international pain experts to plan the path forward into phase 2/3 trials and beyond. It expects to commence its next clinical study in the second half of this year.

https://www.bionity.com/en/news/112681/positive-results-from-phase-1b-study-of-phosphagenics-transdermal-oxycodone-patch.html