Phosphagenics Announces Positive Results From Phase 1B Study Of Transdermal Oxycodone Patch

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials
Article Date: 03 Feb 2010 - 1:00 PDT

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Phosphagenics Limited ("Phosphagenics") (ASX: POH; OTCQX: PPGNY) today announced positive results from a Phase 1B clinical study using the Company's patented TPM™ (Targeted Penetration Matrix) for the transdermal delivery of oxycodone. The results of the successful trial demonstrate that daily application of a TPM™ patch delivers therapeutic levels of oxycodone into the blood stream 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 drug profile appears 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 oxycontin, 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 the 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.

Delivery from the reservoir patch was not as effective as the matrix. Due to the evident superiority of the matrix patch over the reservoir system, as well as its greater potential to reduce drug abuse, Phosphagenics will continue its development program with the matrix patch.

"The oxycodone Phase 1b trial was a very critical study and a milestone for Phosphagenics, going beyond a proof of concept and demonstrating that our patch system can reproducibly deliver therapeutic amounts of oxycodone into the blood stream. The therapeutic blood levels, the rapid elimination and the lack of irritation observed during the study, together with the likelihood that the patch will reduce drug abuse, makes it extremely attractive commercially," said Dr Esra Ogru, Phosphagenics' Chief Operating Officer. "The continued increase in oxycodone concentrations over the duration of the experiment surpassed even our own expectations, and further validates the power of TPM™ for transdermal delivery. We believe that this product will be ideal for management of chronic pain."

As a consequence of this breakthrough 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.

About TPM™

Phosphagenics' TPM™ delivery system is capable of topically delivering small molecules, such as opioids and large molecules such as insulin, into the blood circulation in a non- invasive manner. Phosphagenics has pioneered the development of TPM™ to significantly improve the therapeutic value of many drugs. The oxycodone matrix patch is the fifth product candidate based on Phosphagenics' TPM™ technology to enter clinical development, and the first transdermal system to successfully deliver therapeutic oxycodone plasma concentrations for the management of pain without causing sensitization or irritation.

Several cosmeceutical products utilising TPM™ are currently being commercialised through corporate partners. Other products based on Phosphagenics' TPM™ technology in clinical development include products for the treatment of diabetes, pain, dermatology and other diseases.

About Opioids

Opioid therapies have been and will continue to be a vital part of chronic and acute pain management regimens and U.S. sales of oxycodone, one of the leading drugs for pain management, exceed US$1.5 billion annually. Transdermal delivery of opioids can be advantageous in order to help improve the quality of life of many patients. This mode of drug administration offers many advantages when compared to the traditional oral route of drug delivery, including avoidance of hepatic first-pass metabolism, the potential for long-term controlled release with smoothing of the typical peak-trough plasma drug concentration profiles associated with multiple dosing regimens, the ease of administration, and the possibility of immediate withdrawal of the treatment. Phosphagenics' TPM™ technology is designed to overcome the fact that the majority of the opioids used in clinical practice do not have ideal physicochemical properties that would allow them to reach therapeutic plasma levels by passive skin permeation.

Source
Phosphagenics Limited

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