title: Efficacy of flurbiprofen 8.75 mg lozenge in patients with a swollen and inflamed sore throat.
abstract: Sore throat is often over-treated with antibiotics, therefore there is a need for non-antibiotic treatments that provide effective relief. From the patient's point of view, symptoms of pharyngeal inflammation such as a "swollen" and "inflamed" throat are often considered the most bothersome; so, a non-steroidal anti-inflammatory drug could be an appropriate treatment. We investigated the efficacy and safety of flurbiprofen 8.75 mg lozenge in adults with a swollen and inflamed throat.
  
  
  
  We enrolled adults with moderate-to-severe sore throat and evidence of tonsillo-pharyngitis into a randomized, double-blind study. Patients received flurbiprofen 8.75 mg or placebo lozenges every 3-6 hours as needed (up to five lozenges in 24 hours) and rated their symptoms (sore throat pain, difficulty swallowing and the sensation of a swollen throat) on standard linear scales regularly over 24 hours. The efficacy of flurbiprofen lozenge was determined in patients reporting a swollen and inflamed throat at baseline, as well as those with relatively severe symptoms.
  
  
  
  ClinicalTrials.gov NCT01049334.
  
  
  
  The main outcome measures were the time-weighted summed differences in patient-reported sore throat pain, difficulty swallowing and swollen throat over 24 hours.
  
  
  
  Out of 204 patients, 124 (60.8%) described their throats as swollen and inflamed at baseline. Flurbiprofen lozenges provided greater relief than placebo over 24 hours: 79.8%, 99.6% and 69.3% (for sore throat pain, difficulty swallowing and swollen throat, respectively, all P ≤ 0.01). These outcomes were more substantial in patients with relatively severe symptoms. No serious or unexpected adverse events occurred.
  
  
  
  Flurbiprofen 8.75 mg lozenge appears to provide effective, well-tolerated relief of sore throat, difficulty swallowing and swollen throat in adults with a swollen and inflamed throat, as well as those with relatively severe symptoms. A limitation of these findings is that, while predetermined, these are secondary outcomes derived from a targeted sub-group of patients, not the entire study population.
authors.affiliation: a Reckitt Benckiser Healthcare International Ltd , Slough , Berkshire , UK ;
authors.forename: Sue
authors.initials: S
authors.lastname: Aspley
authors.affiliation: a Reckitt Benckiser Healthcare International Ltd , Slough , Berkshire , UK ;
authors.forename: Adrian
authors.initials: A
authors.lastname: Shephard
authors.affiliation: b Schachtel Research Company , Jupiter , FL , USA ;
authors.forename: Emily
authors.initials: E
authors.lastname: Schachtel
authors.affiliation: b Schachtel Research Company , Jupiter , FL , USA ;
authors.forename: Kathleen
authors.initials: K
authors.lastname: Sanner
authors.affiliation: b Schachtel Research Company , Jupiter , FL , USA ;
authors.forename: Laurie
authors.initials: L
authors.lastname: Savino
authors.affiliation: b Schachtel Research Company , Jupiter , FL , USA ;|c Department of Epidemiology & Public Health , Yale University School of Medicine , New Haven , CT , USA.
authors.forename: Bernard
authors.initials: B
authors.lastname: Schachtel
mesh_terms: D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005480:Flurbiprofen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D010612:Pharyngitis / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000700:Analgesics; D005480:Flurbiprofen
keywords: Acute pain; Flurbiprofen; Inflammation; Non-steroidal anti-inflammatory drug; Pharyngitis; Sore throat; Swollen