Flurbiprofen 8.75 mg Lozenges for Treating Sore Throat Symptoms: A Randomized, Double-Blind, Placebo-Controlled Study

Abstract

Aim: This study assessed multiple doses of flurbiprofen 8.75 mg lozenges for the relief of three prominent symptoms of acute pharyngitis: pain intensity (primary end point), difficulty swallowing and swollen throat. Patients & methods: A total of 204 patients (102 in each group) with confirmed pharyngitis (onset ≤4 days) were randomly assigned to take up to five flurbiprofen or placebo lozenges every 3–6 h, for 7 days. Using validated rating scales (sore throat pain intensity, difficulty swallowing and swollen throat) patients rated their symptoms for the duration of the study. Results: Over the first 24 h, patients treated with flurbiprofen lozenges reported significantly greater reductions in sore throat pain (47%) as well as difficulty swallowing (66%) and swollen throat (40%) compared with placebo (all p < 0.05). Conclusion: Multiple doses of flurbiprofen lozenges provide effective relief of sore throat pain intensity as well as difficulty swallowing and swollen throat.

KEYWORDS:

• acute pharyngitis
• analgesia
• flurbiprofen
• NSAID
• respiratory tract infection
• sore throat
• streptococcal infection

Acknowledgements

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.

Financial & competing interests disclosure

A Shephard, T Shea and S Aspley are employees of Reckitt Benckiser Healthcare International Ltd. BP Schachtel and E Schachtel received an investigational grant from Reckitt Benckiser Healthcare International Ltd to design and conduct this study with K Sanner and L Savino. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing assistance was provided by Hannah Chatfield (Elements Communications Ltd, UK) and funded by Reckitt Benckiser Healthcare International Ltd.

Ethical conduct of research

Ethical approval for this study was obtained from the university’s Institutional Review Board (IRB) and was conducted in accordance with Good Clinical Practice and the Declaration of Helsinki (South Africa, 1996), as referenced in the EU Directive 2001/20/EC. This study also complied with the Code of Federal Regulations (CFR) of the US FDA and was registered on the clinicaltrials.gov registry (NCT01049334). As approved by the IRB, all patients provided written informed consent prior to the study and received financial compensation for their time and any inconvenience. Trial registration: clinicaltrials.gov registry NCT01049334.

Additional information

Funding

A Shephard, T Shea and S Aspley are employees of Reckitt Benckiser Healthcare International Ltd. BP Schachtel and E Schachtel received an investigational grant from Reckitt Benckiser Healthcare International Ltd to design and conduct this study with K Sanner and L Savino. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing assistance was provided by Hannah Chatfield (Elements Communications Ltd, UK) and funded by Reckitt Benckiser Healthcare International Ltd.