Abstract| Volume 14, ISSUE 4, SUPPLEMENT , S72, April 2013

A novel formulation of ibuprofen sodium has a faster onset of analgesia than standard ibuprofen tablets in the treatment of postoperative dental pain

      A novel formulation of ibuprofen sodium (IBUNa) is absorbed faster than standard IBU tablets, and as fast as solubilized IBU and IBU lysinate. The objective of this randomized, double-blind, single-center, 8-hour, inpatient study using the third molar extraction model of dental pain was to compare overall efficacy and onset of analgesia of IBUNa with standard IBU tablets. Subjects (N=316) with at least moderate baseline pain were randomized 2:2:2:1 to receive a single-dose of IBUNa (2x256mg; equivalent to 400mg IBU; n=95), Advil® (IBUAdv; 2x200mg; n=86), Motrin® (IBUMot; 2x200mg; n=87), or placebo (n=48). Primary endpoints were time-weighted sum of pain relief and pain intensity differences over 8 hours (SPRID 0-8) and time to meaningful pain relief (TMPR) as assessed by the double-stopwatch method. The mean SPRID 0-8 score was significantly greater for IBUNa and the other active treatments versus placebo (P<.001). The IBUNa group reported TMPR significantly earlier (median 42.4 minutes) than placebo (>8 hours; P<.001), pooled IBUAdv/IBUMot (median, 55.3 minutes; P<.001), and IBUMot (median, 60.7 minutes; P<.001), and marginally faster than IBUAdv (median, 52.0 minutes; P=.075). By study end, 22.9%, 95.8%, 88.4%, 94.2%, and 82.8% of subjects in the placebo, IBUNa, pooled IBUAdv/IBUMot, IBUAdv, and IBUMot groups, respectively, achieved meaningful relief. Results for secondary endpoints, including time to first perceptible pain relief; SPRID scores over 2, 3, and 6 hours; time to treatment failure; and global evaluation of study treatment, were similar. Most adverse events reported were mild or moderate gastrointestinal disorders (eg, nausea and vomiting) and were similar across treatment groups. Additionally, there were no serious adverse events or discontinuation because of adverse events. This novel formulation of IBUNa provides more rapid onset of analgesia than standard IBU tablets and represents a new treatment option for rapid relief of acute pain. Funded by Pfizer Consumer Healthcare.