Array BioPharma’s pain drug meets Phase II study endpoints

ARRY-797 has achieved its primary and secondary endpoints for analgesic effect and was well-tolerated in this phase II clinical trial. The analgesic effect of 400mg of ARRY-797 administered after surgery, compared to placebo, was statistically significant based upon the primary endpoint of total pain relief over six hours (10.28 for ARRY-797 versus 3.85 for placebo; p<0.0001). The analgesic effect was also statistically significant for total pain relief over three, eight, 12 and 24 hours after dosing. The pain intensity score, which is measured on a visual analog scale from zero to 100mm, also demonstrated significant differentiation between ARRY-797 and placebo for all time periods studied. The area under the curve for pain intensity between zero and six hours was significantly lower for patients receiving ARRY-797 both before and after surgery (200mg per dose), and after surgery (400mg) versus placebo (p=0.0020 and p=0.0013, respectively). At three hours after surgery, the pain intensity was 31.5mm lower in the group receiving ARRY-797 (400mg) after surgery compared to placebo. Patients in this group also reported faster time to meaningful pain relief (p=0.006) and time to onset of analgesia (p=0.0017) relative to placebo. Based on study results, Array has begun a second Phase II acute inflammatory pain trial in 250 patients comparing three doses of ARRY-797 (200, 400 and 600mg) with both placebo and with an active comparator, celecoxib (400mg).