Background: 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 community-based 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 = 249) or placebo spray (n = 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 (AUC0–2h). The change from baseline in other sore throat symptoms also assessed efficacy. Results: The mean AUC0–2h for throat soreness was significantly greater with flurbiprofen spray (−1.82; 95% CI: −1.98 to 1.65) compared with placebo (−1.13; 95% CI: −1.27 to 0.99) (P P Conclusion: Flurbiprofen spray provides rapid and long-lasting relief from sore throat symptoms, and is well-tolerated over three days.
