Caldolor: Phase III data

In a double-blind, U.S. and South African Phase III trial in 185 patients undergoing orthopedic surgery, 800 mg Caldolor every 6 hours met the primary endpoint of significantly reducing pain with movement during hours 6-28 post-surgery vs. placebo. Specifically, Caldolor reduced patient-assessed pain with movement by 26% as measured by VAS scores (p<0.001 compared with placebo). On secondary endpoints, Caldolor significantly reduced patient-assessed pain during rest by 32% and 20% as measured by VAS and VRS scores, respectively, vs. placebo (p<0.001 compared with placebo for both). Additionally, Caldolor led to a significant 31% reduction in morphine use vs. placebo (p<0.001). There was no significant difference between treatment groups in the incidence of bleeding adverse events, blood transfusions or other serious adverse events. Data were published in Pain Medicine. ...