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

Eur J Gen Pract. 2016 Jun;22(2):111-8. doi: 10.3109/13814788.2016.1145650. Epub 2016 Mar 30.


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 < 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.

Keywords: Flurbiprofen; non-steroidal anti-inflammatory; pharyngitis; respiratory tract infections; spray.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Australia
  • Double-Blind Method
  • Female
  • Flurbiprofen / administration & dosage*
  • Flurbiprofen / adverse effects
  • Humans
  • Male
  • Middle Aged
  • New Zealand
  • Pain Measurement
  • Pharyngitis / drug therapy*
  • Pharyngitis / etiology
  • Respiratory Tract Infections / complications
  • Respiratory Tract Infections / drug therapy*
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Anti-Inflammatory Agents, Non-Steroidal
  • Flurbiprofen