Efficacy of flurbiprofen 8.75 mg spray in patients with sore throat due to an upper respiratory tract infection: A randomised controlled trial

Abstract

Pharyngitis (sore throat) is usually caused by viral infections; therefore, antibiotics are generally not warranted. Flurbiprofen 8.75 mg spray (maximum five doses/day, for three days) provides effective symptomatic relief. ABSTRACTBackground: Viral infections cause most cases of pharyngitis (sore throat); consequently, antibiotics are generally not warranted. However, a treatment targeting pain and inflammation, e.g. a topical non-steroidal anti-inflammatory spray, may be helpful for patients. Objective: To evaluate the efficacy and safety of flurbiprofen 8.75 mg spray. Methods: This randomised, double-blind, parallel group study was conducted at six communitybased clinical research centres in Australia and two in New Zealand. Adults with sore throat due to upper respiratory tract infection (onset four days) took one dose of flurbiprofen (n ¼ 249) or placebo spray (n ¼ 256); after six hours, they could re-dose every three-six hours as required, for three days (max. five doses/day). The primary endpoint was the area under the change from baseline curve in throat soreness from zero-two hours (AUC 0-2h ). The change from baseline in other sore throat symptoms also assessed efficacy. Results: The mean AUC 0-2h for throat soreness was significantly greater with flurbiprofen spray (À1.82; 95% CI: À1.98 to 1.65) compared with placebo (À1.13; 95% CI: À1.27 to 0.99) (P < 0.0001). Significantly greater reductions from baseline were observed with flurbiprofen spray compared with placebo from the first time-points assessed (five minutes for throat soreness/difficulty swallowing, 20 minutes for sore throat pain intensity and 30 minutes for swollen throat) for up to six hours (P < 0.05 for all). There was no significant difference in adverse events between treatment groups during the three-day study. Conclusion: Flurbiprofen spray provides rapid and long-lasting relief from sore throat symptoms, and is well-tolerated over three days.

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

“…Our findings support those of previous studies demonstrating that flurbiprofen 8.75 mg provides effective symptomatic relief of sore throats due to URTI when delivered as either a lozenge3,20–24 or a spray 17. Previous studies have compared flurbiprofen 8.75 mg lozenge or spray with placebo.…”

“…To our knowledge, our study is the first that directly compares the relief provided by flurbiprofen 8.75 mg, using two different formats in the same study population. Although this study only monitored efficacy for up to 2 hours post-dose to determine non-inferiority, previous studies have shown that both formulations provide relief for up to 6 hours post-dose,3,17 suggesting that patients may be able to resume normal activities quickly without the need for regular redosing 17…”

“…While patients in this study were recruited from different sources (general practices, community pharmacies, advertizing) and may therefore have presented with a diverse range of symptoms, this may be more representative of “real-world” practice 17. Additionally, although the two products could not be matched due to their different formulations, this was countered by using a double-dummy design: each patient randomized to receive the spray formulation received one dose of flurbiprofen 8.75 mg spray and one placebo lozenge, and patients randomized to receive the lozenge received one flurbiprofen 8.75 mg lozenge and one dose of placebo spray.…”

“…Lozenges allow a high initial deposition of active ingredient in the mouth and throat, while sprays are effective in coating the posterior pharynx16 for rapid delivery to the affected area 17…”

“…Flurbiprofen 8.75 mg lozenges are available over-the-counter in many countries, and they are the only formulation of flurbiprofen currently available in Russia. However, an innovative spray formulation containing flurbiprofen 8.75 mg has recently been developed to provide patients with another treatment option for the relief of sore throat symptoms 17. In the first safety and efficacy study of flurbiprofen 8.75 mg spray, treatment was well tolerated, and rapid, long-lasting relief from sore throat pain and other symptoms was observed 17…”