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 (IBU_Na) 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 IBU_Na (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 IBU_Na for treatment of postoperative dental pain, tension-type headache, or fever. Results: Treatment-emergent AEs (TEAEs) occurred in 5% of cases in the IBU_Na 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 IBU_Na, standard IBU, and placebo, respectively), nervous system disorders (1.4, 3.5, and 3.7% for IBU_Na, standard IBU, and placebo, respectively), and general disorders and administration-site conditions (1.1, 1.5, and 2.1% for IBU_Na, standard IBU, and placebo, respectively). Nausea was the most common TEAE (2.5, 2.6, and 5.9% for IBU_Na, standard IBU, and placebo, respectively). Only two AEs were considered related to treatment: pruritus (n = 1, IBU_Na) and nausea (n = 1, placebo). Of those subjects reporting ≥ 1 TEAE, 44.4, 36.4, and 89.5% of subjects in the IBU_Na, standard IBU, and placebo groups, respectively, received rescue medication. Conclusion: IBU_Na 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.

Keywords:

• adverse event
• analgesic
• antipyretic
• ibuprofen
• ibuprofen sodium
• safety

Acknowledgements

This study was sponsored by Pfizer Consumer Healthcare. Medical writing support was provided by John H Simmons, MD, and Lauren Cerruto of Peloton Advantage, LLC, and was funded by Pfizer. The authors, all employees of Pfizer Consumer Healthcare, Madison, NJ, USA, were responsible for the design, calculation, and interpretation of data, and for the writing of this analysis, as well as for the decision to submit the manuscript for publication. All authors have approved the final article for submission.

Declaration of interest: Shyamalie Jayawardena, PhD, Rina Leyva, MS, and David Kellstein, PhD, are all employees of Pfizer Consumer Healthcare.