Demonstration of functional relief (improved swallowing) by flurbiprofen lozenge

Bernard Schachtel1,2, Sue Aspley3, Adrian Shephard3, Tim Shea3, Gary Smith3, Kathleen Sanner1, Emily Schachtel1, Eve Brignull3. 1Schachtel Research Company, Jupiter, Florida, USA, 2Department of Epidemiology & Public Health, Yale University School of Medicine, New Haven, Connecticut, USA, 3Reckitt Benckiser Healthcare International Ltd, Slough, Berkshire, UK

While most patients with acute pharyngitis seek treatment for throat pain (to relieve a “sore throat”), many patients also complain of “difficulty swallowing” (1) and want improvement in this activity. Because swallowing is the prime function of the throat, we sought to investigate the efficacy of flurbiprofen 8.75 mg lozenge in achieving this functional objective of sore throat treatment.

Ethical approval was obtained from institutional review boards and patients provided written consent before they were enrolled into the study. We interviewed 198 adults with sore throat and found that 54% (106) wanted “help to talk and swallow.” Under double-blind conditions, these 106 patients were randomized to suck one lozenge containing flurbiprofen 8.75 mg or one placebo lozenge. To confirm the diagnosis of pharyngitis, the patients’ physical findings of pharyngitis (tonsillar size, oral mucosal colour, size and number of oral mucosal enanthems, anterior cervical adenopathy and adenitis) were evaluated on the Tonsillo-Pharyngitis Assessment (TPA) (2) . At baseline, and 1 and 2 hours post dose, patients used 100-mm linear scales to rate sore throat pain (odynophagia) on the sore throat pain intensity scale (STPIS) and difficulty swallowing (dysphagia) on the difficulty swallowing scale (DSS) (3). Reduction of sore throat pain and difficulty swallowing were analyzed by determining the difference between treatments in the percentage reductions in STPIS and DSS scores at 1 and 2 hours post dose, and in the time-weighted summed reductions in these scores over 2 hours.

All 106 patients had findings of pharyngitis; most (72%) had enlarged tonsils, with evidence of pharyngeal inflammation (mean TPA 8.4). They described severe throat pain and difficulty swallowing (mean STPIS 80.2 mm, mean DSS 80.0 mm). Significant differences between flurbiprofen and placebo were observed at the first post-dose assessment (1 hour) for the reduction of throat pain (24.7% [19.6 mm] and 14.1% [11.1 mm] reductions from baseline, respectively, p<0.01) and the reduction of difficulty swallowing (25.6% [20.3 mm] and 13.7% [10.9 mm] reductions from baseline, p<0.01). Over 2 hours flurbiprofen-treated patients also reported greater efficacy than placebo: 93% greater reduction of throat pain (41.4 mm*h and 21.4 mm*h, respectively, p<0.01) and 95% greater reduction of difficulty swallowing (41.4 mm*h and 21.2 mm*h, p<0.01).

We conclude that a single lozenge containing flurbiprofen 8.75 mg reduces throat pain and, importantly, also relieves difficulty swallowing, a major functional goal for patients with sore throat.

Trial number and register: NCT01048866; ClinicalTrials.gov

(1) Schachtel BP et al, Arch Int Med 144:497, 1984

(2) Schachtel BP et al, J Pain 12:756, 2011

(3) Schachtel BP et al, Clin Pharmacol Ther 44:704, 1988