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12 Jul 2012

Iroko Pharmaceuticals reports successful Phase 3 clinical trials

A new low-dose treatment for acute pain following surgery has been shown to be effective in Phase 3 trials.

Phase 3 studies of Iroko Pharmaceuticals' investigational submicron indomethacin treatment, which is designed to treat acute post-surgical pain in low doses, have concluded.

According to the results of the study, the drug was effective in significantly improving pain relief in patients when compared with a placebo.

The multicentre study involved treating 462 randomised patients either with low doses of submicron indomethacin (40mg twice or three times daily, or 20mg three times daily), celecoxib or a placebo.

The submicron indomethacin was able to significantly reduce pain over 48 hours at much lower dosages than the celecoxib.

Dr Clarence Young, chief medical officer at the company, explained: "Physicians continue to face the challenge of balancing efficacy with safety when treating patients with pain.

"These top line results led further support to our novel approach to developing new non-steroidal anti-inflammatory drug formulations that may be able to do more with less, a concept that could represent a significant new development in the area of pain management.

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