Pain Therapeutics Inc announced comprehensive results of a 350 patient Phase II study with Oxytrex in osteoarthritic patients. In this study, Oxytrex achieved statistically significant results in the primary endpoint, the secondary endpoints and in patients' functional scores.

"We are excited by these results in patients with severe chronic pain," said Remi Barbier, president and chief executive officer. "In this study, it's clear that patients on Oxytrex had more pain relief, longer lasting pain relief and better physical function compared to patients on an equivalent dose of oxycodone. These clinical data showcase the ability of Oxytrex to outperform oxycodone in a multi-dose, chronic model of pain."

The primary endpoint was prospectively defined as a reduction in pain scores in week three compared to baseline. Oxytrex achieved a statistically significant result in reducing pain intensity during the 21-day treatment period against oxycodone (p=0.006) and against placebo (p<0.001).

Two secondary endpoints were prospectively defined: patients' quality of analgesia and global assessment of analgesia in week three compared to baseline. Oxytrex achieved a statistically significant result in quality of analgesia (p=0.002) compared to the placebo group. Likewise, Oxytrex achieved a statistically significant result in global assessment (p=0.039) compared to the placebo group. By comparison, the p-values for these endpoints for the oxycodone group versus placebo were p=0.052 and p=0.078, respectively.

This study also measured patients' physical function with a widely-used scale called The WOMAC Osteoarthritis Index. WOMAC measures quantitative changes in physical function, such as joint stiffness and range of motion, in patients with osteoarthritis. Oxytrex achieved a statistically significant result with WOMAC Scores (p=0.039) compared to the placebo group. By comparison, the p-value for this endpoint for the oxycodone group versus placebo was p=0.129.