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Phosphagenics oxycodone patch heading toward Phase III

Australian company to have 2 opioid patches in the clinic in 2013
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After a delay in its patch program, Australian drug delivery company Phosphagenics ($PPGNY) has provided an update on its work on its transdermal opioid franchise, including the latest developments on its lead oxycodone patch, which uses its TPM (Targeted Penetration Matrix) transdermal delivery technology.

Opioids are effective painkillers in moderate to severe pain, but have a range of side effects, including constipation, and transdermal delivery could overcome these, as well as make the drugs harder to abuse. The transdermal opioid market is worth more than $1 billion.

Phosphagenics is collaborating with 3M ($MMM) to develop an oxycodone patch to treat chronic pain, a debilitating condition with many causes. This could be the first sustained-release oxycodone patch to reach the market. The partners have worked through crystallization issues and according to Phosphagenics, these have all been resolved and the formulation improved, to the point that a multidose clinical trial is planned for early next year. This will be followed by Phase III trials in the U.S. Resolving crystallization issues is a critical step, particularly for U.S. approval, as otherwise the patch can be open to abuse, and the company had support from German company Labtec.

The company has turned a negative into a positive and used its downtime well--it has taken the opportunity to work on a detailed strategic, clinical and commercial development plan for the oxycodone patch, including a target product profile (TPP) to form part of the final product label.

Phosphagenics is working on other potential opioids that could build a transdermal franchise, including oxymorphone, a semisynthetic opioid. This is more potent than oxycodone, but less bioavailable, and a patch formulation should also be in clinical trials next year.

"The prospect of having two major opioid projects in clinical trials simultaneously represents a significant increase in the value of the program," Phosphagenics CEO Dr. Esra Ogru said to Australian Life Scientist.

- read the press release (pdf)
- see the article in Australian Life Scientist

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