Orexo AB Reports Successful Completion of OX51 Phase II Dose-Finding Study in Prevention of Procedure-Induced Pain

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Uppsala, Sweden – August 28, 2013 – Orexo today announced the successful completion of a dose finding study for OX51 in patients undergoing prostate biopsy, as the study met its primary end-point of analgesic efficacy. The placebo controlled study, which tested sublingual administration of 3 different doses of OX51 and placebo, demonstrated a statistically significant dose response with respect to maximal pain experience during the biopsy procedure. Treatment with OX51 was safe and well-tolerated in all dose groups and no effects on local tolerability in any dose group were observed. In addition OX51 showed no effect on quantitative scales for assessment of sedation and drowsiness compared to placebo.

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