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Demonstration of dose response of flurbiprofen lozenges with the sore throat pain model.

Author(s): Schachtel BP, Homan HD, Gibb IA, Christian J

Affiliation(s): Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT, USA.

Publication date & source: 2002-05, Clin Pharmacol Ther., 71(5):375-80.

Publication type: Clinical Trial; Clinical Trial, Phase II; Comparative Study ; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

The dose response of flurbiprofen lozenges (2.5, 5.0, and 12.5 mg) was evaluated in the treatment of sore throat. A refined version of the sore throat pain model showed that 12.5 mg flurbiprofen was significantly more effective than placebo at providing total pain relief and reducing throat soreness (p <.05). Flurbiprofen, 5.0 mg, was more effective than placebo for the reduction of throat soreness and the sensation of throat swelling (P <.05). The 2.5-mg flurbiprofen lozenge was indistinguishable from placebo. For every milligram of increase in the dose of flurbiprofen, there was an approximately 0.3-unit increase in total pain relief (P <.05). Flurbiprofen lozenges in all 3 dosages were well tolerated. Flurbiprofen lozenges are effective for sore throat at a dose between 5.0 mg and 12.5 mg; the sore throat pain model is a sensitive assay for demonstration of the dose-response relationship of an analgesic agent.

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