Bouroubi A, et al. – The efficacy and safety of a new oromucosal ibuprofen form, ibuprofen 25 mg lozenge were compared with the matched placebo, in the treatment of acute sore throat pain in adults. Outcomes revealed that low-dose ibuprofen 25 mg lozenge in repeat dosing offered more efficacious and rapid relief in sore throat pain in adults. Moreover, ibuprofen 25 mg lozenge was tolerated as well as placebo.

Methods

• In this trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (≥5 on the objective Tonsillo-Pharyngitis Assessment 21-point scale and ≥60 mm on the subjective 0-100 mm visual analogue Sore Throat Pain Intensity Scale [STPIS]) were assigned ibuprofen 25 mg (n=194) or matching placebo (n=191) lozenge treatment.
• Efficacy was evaluated (at the investigating centre up to 2 hours after first dosing, then on an ambulatory basis) by parameters derived from patient's scores on scales of pain relief, pain intensity, and global efficacy assessment.
• The time-weighted TOTal PAin Relief (TOTPAR) over 2 hours after first dosing using the Sore Throat Relief Scale (STRS) was considered as the primary efficacy end-point.
• Safety and local tolerability were evaluated.

Results

• Outcomes revealed that ibuprofen 25 mg was superior to placebo on numerous pain relief parameters; TOTPAR was significantly higher with ibuprofen 25 mg over 2 hours after first dosing (P<.05), the effect being apparent from the first evaluation at 15 minutes (P<.05).
 
• The STPIS reduction in favour of ibuprofen 25 mg was not significant vs placebo.
• Mean STRS scores and patient's global efficacy assessment both reflected a higher efficacy of ibuprofen 25 mg over the 4-day treatment period with tests of statistical significance up to day 1 evening (P<.05), and, in patients with still clinically significant pain (n=128), after an average 4 days (P<.01).
• Ibuprofen 25 mg lozenge was well tolerated with a safety profile similar to placebo.