Efficacy and tolerability of the anti-inflammatory throat lozenge flurbiprofen 8.75mg in the treatment of sore throat - A randomised, double-blind, placebo-controlled study

Objective: This randomised, double-blind, parallel group study compared the efficacy and tolerability of flurbiprofen lozenges (8.75mg or 12.5mg) with demulcent placebo lozenges in the treatment of patients with sore throat d ue to upper respiratory tract infection. Study Participants: A total of 320 patients with objective and subjective evidence of sore throat were random ised to treatment with flurbiprofen 8.75mg (n = 128), flurbiprofen 12.5mg ( n = 64) or placebo (n = 128) lozenges. Main Outcome Measures: Efficacy was assessed by changes in subjective ratings scales measuring pain relief, thr oat soreness and swollen throat at specified intervals over a 6-hour period following administration of a single dose. Tolerability was assessed over a 5-day multiple-dose regimen. Results: Flurbiprofen 8.75mg lozenge was sig nificantly superior to placebo for the primary efficacy variable, total pai n relief summed over 15 to 120 minutes (TOTPAR(15-120 min)), and for reduci ng throat soreness over 2 hours and swollen throat over 2 and 6 hours (p < 0.05). Flurbiprofen 12.5mg treatment was not significantly better than flur biprofen 8.75mg. There were no significant differences between treatment gr oups in the incidence of adverse events when reports of taste perversion, w hich reflects an aspect of patient acceptability rather than tolerability, were removed from the analysis (p = 0.776). Conclusions: The efficacy and t olerability profile of flurbiprofen 8.75mg lozenges indicated that they pro vide a convenient treatment for patients with sore throat. Symptomatic reli ef was rapid, occurring within 15 minutes of administration due to lozenge demulcency, and statistically significant differences between active and pl acebo lozenges were detected within 30 minutes and sustained over 4 hours.