Meaningful Relief with Flurbiprofen 8.75 mg Spray in Patients with Sore Throat due to Upper Respiratory Tract Infection

Abstract

Aim: Evaluate the efficacy of flurbiprofen 8.75 mg spray for sore throat relief. Patients & methods: Randomized, double-blind study in adults with sore throat due to upper respiratory tract infection who took flurbiprofen (n = 249) or placebo spray (n = 256). Pain relief was assessed using the Sore Throat Relief Rating Scale. Results: Flurbiprofen spray provided significantly greater relief versus placebo from 20 min to 6 h (p < 0.0001; maximum difference: 75 min). Sore throat severity was reduced ≥-2.2 on the Sore Throat Scale from 75 min to 6 h, indicating meaningful relief. Significantly more patients taking flurbiprofen spray reported ≥30 min of ‘at least moderate’ relief versus placebo over 6 h (p < 0.0001). Most adverse events were mild. Conclusion: Flurbiprofen spray provides rapid, long-lasting and clinically meaningful relief from sore throat (ANZCTR: ACTRN12612000457842).

Keywords::

• flurbiprofen
• pharyngitis
• spray

Financial & competing interests disclosure

This study was funded by Reckitt Benckiser. A Shephard is an employee of Reckitt Benckiser. R DeVito was a former employee of Reckitt Benckiser. Statistical support was provided by G Smith, a former employee of Reckitt Benckiser. 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 Elements Communications Ltd, Westerham, UK and funded by Reckitt Benckiser.

Ethical conduct of research

The study was conducted according to the Declaration of Helsinki (EU Directive 2001/20/EC) and complied with the International Conference on Harmonisation Good Clinical Practice and regulatory requirements. The study was approved by the Bellberry Human Research Ethics Committee on 19 April 2012 (approval number 2012-03-706) and the Uniting Care Health Human Research Ethics Committee on 4 May 2012 (approval number 1209). All patients provided written informed consent.

Additional information

Funding

This study was funded by Reckitt Benckiser. A Shephard is an employee of Reckitt Benckiser. R DeVito was a former employee of Reckitt Benckiser. Statistical support was provided by G Smith, a former employee of Reckitt Benckiser. 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 Elements Communications Ltd, Westerham, UK and funded by Reckitt Benckiser