Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo

Abstract

Background: Ibuprofen (IBU) is an efficacious over-the-counter analgesic/antipyretic with adverse event (AE) rates comparable to placebo. IBU sodium (IBUNa) is a newer, more soluble form that is absorbed faster than standard IBU, leading to more rapid analgesia. Although its safety and tolerability are expected to be comparable to standard IBU, this has not yet been reported. Methods: Pooled analysis comparing the safety of single-dose IBUNa (512 mg; equivalent to 400 mg IBU free acid; n = 362) with standard IBU tablets (400 mg; n = 342) and placebo (n = 187) across five Phase III, randomized, placebo-controlled, double-blind studies evaluating IBUNa for treatment of postoperative dental pain, tension-type headache, or fever. Results: Treatment-emergent AEs (TEAEs) occurred in 5% of cases in the IBUNa group (25 events), 6.4% of cases in the standard IBU group (41 events), and 10.2% of cases in the placebo group (31 events). The most frequent TEAEs were in the following Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes: gastrointestinal disorders (2.8, 3.2, and 5.9% for IBUNa, standard IBU, and placebo, respectively), nervous system disorders (1.4, 3.5, and 3.7% for IBUNa, standard IBU, and placebo, respectively), and general disorders and administration-site conditions (1.1, 1.5, and 2.1% for IBUNa, standard IBU, and placebo, respectively). Nausea was the most common TEAE (2.5, 2.6, and 5.9% for IBUNa, standard IBU, and placebo, respectively). Only two AEs were considered related to treatment: pruritus (n = 1, IBUNa) and nausea (n = 1, placebo). Of those subjects reporting ≥ 1 TEAE, 44.4, 36.4, and 89.5% of subjects in the IBUNa, standard IBU, and placebo groups, respectively, received rescue medication. Conclusion: IBUNa has a favorable safety profile comparable to those of standard IBU tablets and placebo in single-dose studies evaluating analgesic or antipyretic efficacy. ClinicalTrials.gov Registry Numbers: Dental pain studies: NCT01098747 and NCT01216163; headache studies: NCT01077973 and NCT01362491; pyresis study: NCT01035346.