OXYTREX PHASE III TRIAL RESULTS INADEQUATE

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Pain Therapeutics has reported that its Phase III study of Oxytrex was inadequate due to patient dropouts. The number of patients who completed the osteoarthritis study was lower than expected, and statistical significance was not reached in reducing opioid-related physical dependency, the trial's primary endpoint.

Oxytrex, a combination of oxycodone with ultra-low-dose naltrexone, reduced physical dependency by 28 percent compared to an equivalent dose of oxycodone, exceeding Pain Therapeutics' expectation of such a reduction by 25 percent or more, but well below the statistical significance threshold. The trial did hit statistical significance in a subgroup analysis, as Oxytrex reduced physical dependency by 75 percent in patients older than 50.