Dec 2 2009
Phosphagenics Limited (“Phosphagenics”) (ASX: POH; OTCQX: PPGNY) today announced the initiation of a Phase 1B clinical trial for its patented oxycodone/TPM (Targeted Penetration Matrix) transdermal patch systems.
The clinical trial consists of a pharmacokinetic study in twenty healthy volunteers at the Royal Adelaide Hospital under the guidance of Principal Investigator, Professor Guy Ludbrook, Professor of Anaesthesia, University of Adelaide. The primary objective of the Company’s Phase 1B clinical trial is to compare systemic levels of oxycodone for the two transdermal patch candidates, the matrix and reservoir systems. Each of the twenty subjects will be administered with an oxycodone patch on a once daily basis for up to ten days. Systemic oxycodone levels will be monitored to assess which of the two patch systems can deliver sustained therapeutic levels of oxycodone into the blood stream.
The results of the Phase 1B trial are scheduled to be completed by early 2010 and will determine the best candidate for commercial development. The Phase II/III oxycodone clinical trials are scheduled for 2010.
According to Phosphagenics’ Chief Operating Officer, Dr Esra Ogru, the TPM/oxycodone patch system appears potentially suitable for chronic pain management. “The results of our first clinical trial earlier this year were a world first and were suggestive of the potential for the TPM system to change the way in which chronic pain is treated in the future,” she said.
“Currently, patients treated with oral oxycodone obtain pain relief for only a short period of time. The earlier human trial conducted by Phosphagenics, indicates that our oxycodone patch may provide sustained drug delivery for a matter of days. This trial will help determine just how long we can provide patients with sustained pain relief.”
Phosphagenics aims to become the first company to offer chronic pain sufferers an oxycodone patch that will provide sustained pain relief. In an Australian clinical trial conducted earlier this year on 50 subjects, Phosphagenics demonstrated that its formulation did not cause sensitisation or irritation, the major barriers preventing the use of most opioids in topical delivery systems. In addition to oxycodone, it is highly likely that the TPM patch system may have application to the majority of opioids, giving clinicians several alternatives in the treatment of chronic pain.
US sales of oxycodone exceed US$1.5 billion annually. Although oxycodone, an opioid derivative, is more potent than morphine, it produces less adverse side effects. It has become the drug of choice for chronic pain management of patients suffering from debilitating diseases such as cancer. Currently the drug can be administered orally or intravenously.
SOURCE Phosphagenics Limited
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