A new onset-of-action model was utilized to distinguish the pharmacologic activity of
flurbiprofen 8.75mg delivered in a lozenge from the demulcent effect of the lozenge base. In a randomized, double-blind, placebo-controlled trial, patients with
sore throat rated
pain on a
Sore Throat Pain Intensity Scale before taking one
flurbiprofen or placebo lozenge and at frequent (2-minute) intervals over the first hour
after treatment. Further ratings of the
Sore Throat Pain Intensity Scale and other patient-reported outcomes (difficulty swallowing, swollen throat,
pain relief) were obtained at varying intervals over 6 hours. Onset of pharmacologic activity was defined as the median time of first perceived
pain reduction if a patient reported clinically meaningful (at least moderate) relief. The conventional method of comparing mean treatment responses at each time point was also implemented. Demulcent action was detected at the first 2-minute assessment. By the new method, 102
flurbiprofen-treated patients were identified as first perceiving
pain relief at 12 minutes, compared with >120 minutes by 102 patients using placebo (P<0.001). By the conventional method, mean percentage
pain reduction for
flurbiprofen 8.75 mg was first significantly differentiated from placebo at 26 minutes (P<0.05). Efficacy of
flurbiprofen lozenge was demonstrated for 3.5-4hours on the 4 patient-reported outcomes (all P<0.05 compared with placebo). There were no serious adverse events. This patient-centered onset-of-action model identifies the initiation of
pain relief in patients who are definite drug responders, here demonstrating that a
flurbiprofen 8.75-mg lozenge provides early relief of
sore throat.