(363) Demonstration of clinically important relief and the percent change in pain intensity at the time of meaningful relief by flurbiprofen 8.75 mg lozenge

Abstract

A lozenge containing 8.75 mg of the non-steroidal anti-inflammatory drug flurbiprofen has been developed for the treatment of sore throat. We used the double-stopwatch method to evaluate the onset of its pharmacologic activity. To determine the % pain intensity difference (PID) at the time of meaningful relief (tMR) and whether it was clinically important, we included measurements at tMR on a 100-mm linear scale, the Sore Throat Pain Intensity Scale (STPIS). At baseline, adults with recent-onset moderate/severe sore throat and tonsillo-pharyngitis rated pain on the STPIS and an 11-point numerical rating scale, the Sore Throat Scale (STS), and were randomized under double-blind conditions to one flurbiprofen or placebo lozenge. Two stopwatches were started: patients depressed one stopwatch when they first perceived any relief and the second when they experienced meaningful relief (tMR). Patients rated pain on the STS every 5 minutes and on the STPIS at tMR. For the flurbiprofen group (n=101), median tMR was 43 minutes. (For the placebo group, median tMR could not be calculated because >50% of placebo-treated patients did not report meaningful relief.) Mean reduction in STS for flurbiprofen-treated patients at 45 minutes (closest time-point to the median tMR) was 2.2, corresponding to 30% PID, consistent with a “clinically important” change on an 11-point numerical rating scale.1 Mean % PID on the STPIS at the tMR was 42%, consistent with acute pain patients’ achieving “definite improvement”2 and “much improvement”.3 These findings not only demonstrate the onset of clinically significant pharmacologic activity of flurbiprofen lozenge but also provide a framework for interpreting changes on linear and numerical rating scales that can be applied to other pain trials. (1. Farrar, J Pain Symptom Manage, 2003; 2. Schachtel, J Pain, 2013; 3. Cepeda, Pain, 2003.) Supported by a grant from Reckitt Benckiser. A lozenge containing 8.75 mg of the non-steroidal anti-inflammatory drug flurbiprofen has been developed for the treatment of sore throat. We used the double-stopwatch method to evaluate the onset of its pharmacologic activity. To determine the % pain intensity difference (PID) at the time of meaningful relief (tMR) and whether it was clinically important, we included measurements at tMR on a 100-mm linear scale, the Sore Throat Pain Intensity Scale (STPIS). At baseline, adults with recent-onset moderate/severe sore throat and tonsillo-pharyngitis rated pain on the STPIS and an 11-point numerical rating scale, the Sore Throat Scale (STS), and were randomized under double-blind conditions to one flurbiprofen or placebo lozenge. Two stopwatches were started: patients depressed one stopwatch when they first perceived any relief and the second when they experienced meaningful relief (tMR). Patients rated pain on the STS every 5 minutes and on the STPIS at tMR. For the flurbiprofen group (n=101), median tMR was 43 minutes. (For the placebo group, median tMR could not be calculated because >50% of placebo-treated patients did not report meaningful relief.) Mean reduction in STS for flurbiprofen-treated patients at 45 minutes (closest time-point to the median tMR) was 2.2, corresponding to 30% PID, consistent with a “clinically important” change on an 11-point numerical rating scale.1 Mean % PID on the STPIS at the tMR was 42%, consistent with acute pain patients’ achieving “definite improvement”2 and “much improvement”.3 These findings not only demonstrate the onset of clinically significant pharmacologic activity of flurbiprofen lozenge but also provide a framework for interpreting changes on linear and numerical rating scales that can be applied to other pain trials. (1. Farrar, J Pain Symptom Manage, 2003; 2. Schachtel, J Pain, 2013; 3. Cepeda, Pain, 2003.) Supported by a grant from Reckitt Benckiser.