A novel formulation of ibuprofen sodium has a safety profile comparable to standard ibuprofen tablets: a pooled analysis of randomized clinical trials

Abstract

A desirable attribute of over-the-counter analgesics/antipyretics such as ibuprofen (IBU) is rapid onset of action; therefore, faster-absorbed formulations have been developed. Pharmacokinetic studies demonstrate that a novel formulation of IBU sodium (IBUNa) is absorbed faster than standard IBU tablets, and as fast as solubilized IBU and IBU lysinate. Clinical studies demonstrate that this formulation of IBUNa provides more rapid pain relief than standard IBU tablets for the treatment of dental pain. The objective of this pooled analysis, which included 5, double-blind, randomized clinical trials evaluating dental pain (2 trials), tension-type headache (2 trials), and fever (1 trial), was to compare the safety profile of a single dose (equivalent to 400 mg) of IBUNa (n=362) with standard IBU tablets (n=342) and placebo (n=187). In total, 5.0%, 6.4%, and 10.2% of subjects in the IBUNa, standard IBU, and placebo groups experienced 25, 41, and 31 treatment-emergent adverse events (TEAEs), respectively. Significantly more placebo-treated subjects had a TEAE than subjects in the IBUNa group (P=.03). The most frequent TEAEs occurring in ≥2% of subjects in the IBUNa, standard IBU, and placebo groups, respectively, were in the following MedDRA system organ classes: gastrointestinal disorders (2.8%, 3.2%, and 5.9%), nervous system disorders (1.4%, 3.5%, and 3.7%), and general disorders and administration site conditions (1.1%, 1.5%, and 2.1%). Only 2 AEs were considered treatment-related; pruritus and nausea in the IBUNa and placebo groups, respectively. Of those reporting at least 1 TEAE, 44.4%, 36.4%, and 89.5% of subjects in the IBUNa, standard IBU, and placebo groups, respectively, received rescue medication. These data demonstrate that the safety profile of IBUNa is no worse than placebo and comparable to that of standard IBU tablets in single-dose studies evaluating analgesic or antipyretic efficacy. Therefore, this novel, faster-acting formulation of IBUNa has a favorable safety profile. Funded by Pfizer Consumer Healthcare. A desirable attribute of over-the-counter analgesics/antipyretics such as ibuprofen (IBU) is rapid onset of action; therefore, faster-absorbed formulations have been developed. Pharmacokinetic studies demonstrate that a novel formulation of IBU sodium (IBUNa) is absorbed faster than standard IBU tablets, and as fast as solubilized IBU and IBU lysinate. Clinical studies demonstrate that this formulation of IBUNa provides more rapid pain relief than standard IBU tablets for the treatment of dental pain. The objective of this pooled analysis, which included 5, double-blind, randomized clinical trials evaluating dental pain (2 trials), tension-type headache (2 trials), and fever (1 trial), was to compare the safety profile of a single dose (equivalent to 400 mg) of IBUNa (n=362) with standard IBU tablets (n=342) and placebo (n=187). In total, 5.0%, 6.4%, and 10.2% of subjects in the IBUNa, standard IBU, and placebo groups experienced 25, 41, and 31 treatment-emergent adverse events (TEAEs), respectively. Significantly more placebo-treated subjects had a TEAE than subjects in the IBUNa group (P=.03). The most frequent TEAEs occurring in ≥2% of subjects in the IBUNa, standard IBU, and placebo groups, respectively, were in the following MedDRA system organ classes: gastrointestinal disorders (2.8%, 3.2%, and 5.9%), nervous system disorders (1.4%, 3.5%, and 3.7%), and general disorders and administration site conditions (1.1%, 1.5%, and 2.1%). Only 2 AEs were considered treatment-related; pruritus and nausea in the IBUNa and placebo groups, respectively. Of those reporting at least 1 TEAE, 44.4%, 36.4%, and 89.5% of subjects in the IBUNa, standard IBU, and placebo groups, respectively, received rescue medication. These data demonstrate that the safety profile of IBUNa is no worse than placebo and comparable to that of standard IBU tablets in single-dose studies evaluating analgesic or antipyretic efficacy. Therefore, this novel, faster-acting formulation of IBUNa has a favorable safety profile. Funded by Pfizer Consumer Healthcare.