This Phase II randomized study enrolled 253 patients with postsurgical pain. Three doses of ARRY-797 (200mg, 400mg and 600mg) were compared to placebo and celecoxib (400mg). In the primary efficacy measure of total pain relief over six hours post dose (p<0.001), ARRY-797 produced a dose-dependent analgesic response, compared to placebo. ARRY-797 (400 and 600mg) and celecoxib (400mg) demonstrated significant analgesic benefit, robust pain relief, and good duration of analgesia, the company said. Patients requiring rescue medication six to 18 hours following dosing, administration of a second 200mg dose of ARRY-797 resulted in statistically significant pain relief compared to placebo (p<0.008). No serious adverse events were reported in the ARRY-797 treated groups, and the overall incidence of adverse events was similar across all treatment groups. Array also presented results from two previous ARRY-797 trials. In the first Phase II dental pain study, CRP levels, a biomarker of systemic inflammation and cardiovascular disease, were measured. Compared to placebo, ARRY-797 reduced CRP by 85% on the day following surgery. In a Phase I study, ARRY-797 significantly inhibited the inflammatory cytokines TNF and IL-1 and the pain mediator PGE2 out to 24 hours post-dose. Array is also conducting a 12-week study of ARRY-797 in ankylosing spondylitis (AS), a painful inflammatory condition, which will begin patient recruitment before the end of 2008. This study will enroll over 160 patients and is planned to provide efficacy data in the first half of 2010. The reported positive analgesic results, coupled with the inflammatory cytokine inhibition, provide additional support for the potential clinical benefit to AS patients. Kevin Koch, president and chief scientific officer of Array BioPharma, said: "These results, together with our multiple-dose, 14-day trial in healthy volunteers, confirm that ARRY-797 is well-tolerated at doses that provide acute analgesic benefit and systemic anti-inflammatory activity. In view of our tolerability profile, we are exploring higher doses of ARRY-797 and evaluating additional trials in sub-chronic pain indications."