Efficacy of flurbiprofen 8.75 mg lozenge in patients with a swollen and inflamed sore throat

Abstract

Objective: Sore throat is often over-treated with antibiotics, therefore there is a need for non-antibiotic treatments that provide effective relief. From the patient’s point of view, symptoms of pharyngeal inflammation such as a “swollen” and “inflamed” throat are often considered the most bothersome; so, a non-steroidal anti-inflammatory drug could be an appropriate treatment. We investigated the efficacy and safety of flurbiprofen 8.75 mg lozenge in adults with a swollen and inflamed throat.

Research design and methods: We enrolled adults with moderate-to-severe sore throat and evidence of tonsillo-pharyngitis into a randomized, double-blind study. Patients received flurbiprofen 8.75 mg or placebo lozenges every 3–6 hours as needed (up to five lozenges in 24 hours) and rated their symptoms (sore throat pain, difficulty swallowing and the sensation of a swollen throat) on standard linear scales regularly over 24 hours. The efficacy of flurbiprofen lozenge was determined in patients reporting a swollen and inflamed throat at baseline, as well as those with relatively severe symptoms.

Clinical trial registration: ClinicalTrials.gov NCT01049334.

Main outcome measures: The main outcome measures were the time-weighted summed differences in patient-reported sore throat pain, difficulty swallowing and swollen throat over 24 hours.

Results: Out of 204 patients, 124 (60.8%) described their throats as swollen and inflamed at baseline. Flurbiprofen lozenges provided greater relief than placebo over 24 hours: 79.8%, 99.6% and 69.3% (for sore throat pain, difficulty swallowing and swollen throat, respectively, all P ≤ 0.01). These outcomes were more substantial in patients with relatively severe symptoms. No serious or unexpected adverse events occurred.

Conclusions: Flurbiprofen 8.75 mg lozenge appears to provide effective, well-tolerated relief of sore throat, difficulty swallowing and swollen throat in adults with a swollen and inflamed throat, as well as those with relatively severe symptoms. A limitation of these findings is that, while predetermined, these are secondary outcomes derived from a targeted sub-group of patients, not the entire study population.

Keywords:

• Acute pain
• Flurbiprofen
• Inflammation
• Non-steroidal anti-inflammatory drug
• Pharyngitis
• Sore throat
• Swollen

Transparency

Declaration of funding

This study was sponsored by Reckitt Benckiser Healthcare International Ltd, UK.

Declaration of financial/other relationships

S.A. and A.S. have disclosed that they are employees of Reckitt Benckiser Healthcare International Ltd. B.S. and E.S. have disclosed that they received an investigational grant from Reckitt Benckiser Healthcare International Ltd to design and conduct this study with K.S. and L.S. K.S. and L.S. declare no conflicts of interests.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Medical writing assistance was provided by Papia Das (Elements Communications Ltd, Westerham, UK) and funded by Reckitt Benckiser Healthcare International Ltd. The authors would like to thank Gary Smith for his role in the initial analysis and interpretation of the data, and for his help in drafting the original submitted version of the manuscript. The authors would also like to thank Antonio Cagnazzo for his further analysis and interpretation of the data.

Previous presentation: Some of the data have been previously published as an abstract (and presented as a poster): Schachtel B, et al. Efficacy of flurbiprofen 8.75mg lozenges in patients with swollen/inflamed sore throat. 14th World Congress on Pain, 27–31 August 2012, Milan, Italy.