Phosphagenics expanding pain patch program

Phosphagenics (ASX:POH) is back on track with the clinical development of pain patch TPM-oxycodone after resolving technical issues and has started development of a new opioid-based patch.

The drug delivery company confirmed it had resolved the crystallisation issues with the original design of the TPM-oxycodone patch. Preventing crystallisation is an important part of preventing abuse of the oxydocone and gaining regulatory approval.

In May, Phosphagenics announced it had contracted Germany's Labtec to help design the final commercial candidate for the patch, after encountering crystallisation issues with the prototypes developed in collaboration with 3M. The redesign had delayed the company's patch program.

But with the issues solved, Phosphagenics expects to commence a multi-dose trial early next year and submit an Investigational New Drug application with the US FDA once the study concludes.

Phosphagenics said it had drawn up a detailed Target Product Profile and a Clinical Development Plan for the product during the delay.

The company is meanwhile preparing to develop new opioid pain patches modelled on TPM-Oxycodone and Phosphagenics’ Targeted Penetration Matrix drug delivery technology.

The first patch will likely use oxymorphone, a semi-synthetic opioid similar to oxycodone.

If pre-clinical work goes well, the company plans to launch a single-dose clinical trial of an oxymorphone patch in early 2013, concurrent with the TPM-Oxycodone trial.

“The prospect of having two major opioid projects in clinical trials simultaneously represents a significant increase in the value of the [oxycodone] program,” Phosphagenics CEO Dr Esra Ogru said.

Phosphagenics (ASX:POH) shares were trading up half a cent at 15c at Monday’s close.