Efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection: a randomized, non-inferiority trial in the Russian Federation

Abstract

ObjectiveTo 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 methodsThis 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.ResultsReductions 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.ConclusionBoth 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.

Improvements in throat function and qualities of sore throat from locally applied flurbiprofen 8.75 mg in spray or lozenge format: findings from a randomized trial of patients with upper respiratory tract infection in the Russian Federation

“…All participants in the trial provided written informed consent. The methodology for this trial was reported previously, 20 and is briefly described below.…”

“…The primary objective of a recent, randomized, non-inferiority, active comparator study was to assess the efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with ST due to URTI. 20 Here, we focus on the speed of relief provided by flurbiprofen 8.75 mg spray and lozenge in that study, as well as the improved throat function resulting from treatment. This analysis concentrates on the effect of flurbiprofen 8.75 mg spray and lozenge on many of the different qualities and characteristics of ST pain and discomfort, and the many articulations of the broad term “ST”.…”

Validation of an analytical method to quantify the permeation and penetration of flurbiprofen into human pharynx tissue

“…Flurbiprofen is a nonsteroidal anti‐inflammatory drug which, when delivered as a spray or lozenge, provides rapid relief from pharyngitis (sore throat) (de Looze et al, ; Radkova, Burova, Bychkova, & DeVito, ; Schachtel et al, ; Schachtel, Shephard, et al, ; Schachtel, Aspley, et al, ). This suggests that flurbiprofen works locally, rather than requiring absorption into the systemic circulation.…”

“…Previous studies have shown that flurbiprofen is absorbed across the buccal mucosa (Barsuhn, Olanoff, Gleason, Adkins, & Ho, ; Gonzalez‐Younes, Wagner, Gaines, Ferry, & Hageman, ); however, the extent of penetration into the pharynx tissue is yet to be confirmed. Movement of flurbiprofen deeper into the layers of pharynx tissue would suggest that it acts locally on peripheral nerves located deep within the tissue and would be commensurate with its rapid onset of action (de Looze et al, ; Radkova et al, ; Schachtel et al, ; Schachtel, Aspley, et al, ; Schachtel, Shephard, et al, ).…”

Bactericidal activity of hexylresorcinol lozenges against oropharyngeal organisms associated with acute sore throat

“…The most frequent cause of acute sore throat is a viral infection, responsible for up to 80% of cases in adults [2]. Bacterial infections are estimated to cause 5-15% of acute sore throat cases in adults [3][4][5]. Streptococcus pyogenes (also known as group A β-hemolytic Streptococcus or GABHS) is the most common bacterial cause of acute sore throat [3,5], although other bacterial species have been implicated, including Staphylococcus aureus [6], Moraxella catarrhalis [7], Haemophilus influenzae [8] and Fusobacterium necrophorum [9].…”