Caldolor: Phase III data

A double-blind, international Phase III trial in 120 hospitalized patients with fever showed that Caldolor met the primary endpoint of a significantly greater proportion of patients achieving a temperature <101.0 degrees F at 4 hours from baseline vs. placebo (77% vs. 32%, p=0.0005). The trial also met the secondary endpoints of a significantly greater proportion of patient receiving 100 and 200 mg Caldolor achieving a temperature <101.0 degrees F at 4 hours from baseline vs. placebo (61% and 70%, p=0.0264 and p=0.0043, respectively). Similar reductions in temperature were seen in critically ill patients (N=53), defined as those receiving mechanical ventilation and/or vasopressor support. ...