Onset of action of a lozenge containing flurbiprofen 8.75 mg: A randomized, double-blind, placebo-controlled trial with a new method for measuring onset of analgesic activity

Abstract

A new onset-of-action model was utilized to distinguish the pharmacologic activity of flurbiprofen 8.75mg delivered in a lozenge from the demulcent effect of the lozenge base. In a randomized, double-blind, placebo-controlled trial, patients with sore throat rated pain on a Sore Throat Pain Intensity Scale before taking one flurbiprofen or placebo lozenge and at frequent (2-minute) intervals over the first hour after treatment. Further ratings of the Sore Throat Pain Intensity Scale and other patient-reported outcomes (difficulty swallowing, swollen throat, pain relief) were obtained at varying intervals over 6 hours. Onset of pharmacologic activity was defined as the median time of first perceived pain reduction if a patient reported clinically meaningful (at least moderate) relief. The conventional method of comparing mean treatment responses at each time point was also implemented. Demulcent action was detected at the first 2-minute assessment. By the new method, 102 flurbiprofen-treated patients were identified as first perceiving pain relief at 12 minutes, compared with >120 minutes by 102 patients using placebo (P<0.001). By the conventional method, mean percentage pain reduction for flurbiprofen 8.75 mg was first significantly differentiated from placebo at 26 minutes (P<0.05). Efficacy of flurbiprofen lozenge was demonstrated for 3.5-4hours on the 4 patient-reported outcomes (all P<0.05 compared with placebo). There were no serious adverse events. This patient-centered onset-of-action model identifies the initiation of pain relief in patients who are definite drug responders, here demonstrating that a flurbiprofen 8.75-mg lozenge provides early relief of sore throat.

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

“…[22,23] In this study, flurbiprofen spray provided at least 30 minutes of at least moderate relief in a higher proportion of patients, and previously patient perception of at least moderate relief from acute pain has been shown to be clinically important. [28] Many patients visit physicians with sore throat and in a questionnaire-based study in Belgium, the top two reasons for visiting a doctor were to establish the cause (85.5%) and seek pain relief (84.5%); hopes for an antibiotic only ranked 11th out of 13 items (37.6%).…”

“…five points on the Tonsillo-Pharyngitis Assessment (TPA), an index of seven physician-assessed objective features of pharyngitis. [23,24] Patients were ineligible if they had any evidence of mouth breathing, severe coughing, any allergy and/or intolerance to the study drug, formulation ingredients or hypersensitivity to paracetamol. Standard warnings and contraindications for NSAIDs were used to assess patient eligibility.…”

“…The study was conducted on an established drug formulation, over a short period, and the study design was robust and used well-validated methodologies. [23,24,26,27] Patients in both groups took a similar number of doses over three days, enabling a fairer comparison between treatments. However, patients were recruited from different sources (general practice, community pharmacy or advertisements) and may have had a diverse range of symptoms although this would more accurately represent the patient population.…”

“…[3,21] Previous studies have demonstrated the efficacy of flurbiprofen lozenge and granule formulations (8.75 mg per dose) for symptomatic relief of sore throat. [22][23][24] Recently, an innovative spray formulation containing 8.75 mg of flurbiprofen per dose has been developed for sore throat symptom relief. The spray formulation offers advantages such as rapid delivery to the affected area and is convenient to use.…”

“…The methods used were based on the validated Sore Throat Pain Model, which has been used for studies of flurbiprofen 8.75 mg lozenge. [23,24,26,27] …”