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Phosphagenics to initate Ph 2 trial of pain reducing patch

09 December 2014 | Regulatory | By BioSpectrum Bureau

Phosphagenics to initate Ph 2 trial of pain reducing patch

The patch can transport oxycodone across intact skin

The patch can transport oxycodone across intact skin

Singapore: Australian drug delivery company, Phosphagenics, has received regulatory nod to commence proof of concept of Phase 2 trial in Australia for its TPM/Oxycodone patch to examine its effectiveness in reducing pain in patients suffering from post-herpetic neuralgia (PHN).

PHN is a well-accepted neuropathic pain model. The US FDA has commonly granted orphan drug status to drugs being developed to treat PHN.

While several studies have demonstrated that inflammation in peripheral tissues causes the up-regulation of opioid receptors, opioids delivered into the skin via a patch have never before been successfully applied to treat peripheral pain, including neuropathic pain, in humans. Positive results in this trial will open up new market opportunities and indications for oxycodone.

Phosphagenics has demonstrated that TPM can transport oxycodone across intact skin in a rodent model and act directly on inflamed tissue to provide local pain relief.

Dr Paul Gavin, CSO of Phosphagenics, said, "It is very exciting to get our first opioid patch into formal Phase 2 pain studies, especially as we are trialing a new application for this existing drug. Clearly, an opioid product with little or no systemic delivery that greatly reduces most of the common adverse side effects caused by opioids while providing localised pain relief would be a unique and extremely valuable product."

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