ARRY-797: Phase II data

A double-blind, U.S. Phase II trial in 157 patients with OA of the knee who had moderate to severe chronic pain despite NSAID use showed that twice-daily 400 mg oral ARRY-797 met the primary endpoint of reducing mean WOMAC pain subscale scores from baseline to day 28 vs. placebo (2.4 vs. 1.6 point reduction, p=0.0247). Array said that ARRY-797 had a comparable reduction on the endpoint to that of the active control oxycodone ER. The company also said that ARRY-797 showed improvements relative to placebo on the secondary endpoints of WOMAC stiffness and physical function subscale scores, responder analysis and PGIC, but did not disclose details.

ARRY-797 was well tolerated with dizziness, diarrhea and nausea reported as the most common adverse events. Array also said that ARRY-797 was associated with transient increases in creatine kinase and aspartate aminotransferase (AST) levels. Furthermore, mild prolongations of the corrected QT (QTc) interval and sustained reductions in systolic and diastolic blood pressure were reported. Rates of discontinuation due to adverse events were 6% for ARRY-797, 34% for oxycodone ER and 8% for placebo. All patients continued to receive NSAID therapy throughout the trial. ...