Abstract
Objective
To assess the efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection (URTI).
Materials and methods
This multicenter, double-blind, double-dummy, non-inferiority study randomized 440 adults with recent-onset, moderate-to-severe sore throat due to URTI to a single dose of either flurbiprofen 8.75 mg spray (n=218) or flurbiprofen 8.75 mg lozenge (n=222). The presence or absence of beta-hemolytic streptococci (A or C) was confirmed by culture tests (throat swab). The primary efficacy end point was the difference from baseline to 2 hours post-dose in sore throat pain intensity scale (STPIS pain intensity difference [PID] 2h), a validated 100 mm visual analog scale (from 0=“no pain” to 100=“severe pain”), with a non-inferiority margin of −6 mm. Secondary end points included STPIS PID at 1 hour (STPIS PID 1h) and over 2 hours (STPIS sum of sore throat pain intensity differences [SPID]0–2h) and ratings of patient satisfaction and investigator assessment of drug efficacy at 2 hours. Safety (adverse events [AEs]) was also assessed.
Results
Reductions in sore throat pain intensity at 2 hours (STPIS PID 2h) were similar for spray (least square mean −40.51) and lozenge (−40.10) (difference: 0.41, 95% confidence interval [95% CI] −3.20, 4.01), with non-inferiority demonstrated. Subgroup analyses showed similar efficacy (STPIS PID 2h) for patients testing positive or negative for Strep A or C. There was no significant difference between spray and lozenge in STPIS PID 1h or STPIS SPID0–2h, and patient satisfaction and investigators’ assessment of efficacy at 2 hours were similar for both groups. There were no significant differences in AEs between the two groups, with 17 drug-related events across both groups, all being mild and none being serious.
Conclusion
Both formulations demonstrated comparable efficacy and safety profiles and provide patients with two different treatment formats to choose from for effective symptomatic relief of sore throat, depending on their preference.
Keywords:
Supplementary material
Table S1 Institutional ethics committees at each investigational site
Acknowledgments
Medical writing assistance was provided by Hannah Chatfield at Elements Communications Ltd, Westerham, UK, and was funded by Reckitt Benckiser Healthcare Ltd, Slough, UK.
Author contributions
All authors contributed toward data analysis, drafting and critically revising the paper and agree to be accountable for all aspects of the work.
Disclosure
Valeria Bychkova and Robert DeVito are employees of Reck-itt Benckiser. This study was funded by Reckitt Benckiser. Dr Eugenia Radkova received funding from Reckitt Benckiser to develop the content of all study-related documents (protocol, ICF, IB, CSR). Professor Natalia Burova’s organization (Federal State Establishment Clinical Diagnostic Medical Center) received funding from Reckitt Benckiser for the study. The authors report no other conflicts of interest in this work.