Efficacy and safety of single and multiple doses of a fixed-dose combination of ibuprofen and acetaminophen in the treatment of postsurgical dental pain: Results from 2 phase 3, randomized, parallel-group, double-blind, placebo-controlled studies.

OBJECTIVES:

A previous pilot study demonstrated that various fixed-dose combinations (FDCs) of ibuprofen (IBU) and acetaminophen (APAP) provided analgesic efficacy comparable to a higher dose of IBU, with the same safety profile. These studies further evaluated the chosen FDC IBU/APAP 250/500 mg formulation.

MATERIALS AND METHODS:

Two phase 3 dental pain studies enrolled healthy young patients with ≥ moderate pain after ≥ 3 third molar extractions who received single-dose FDC IBU/APAP 250/500 mg, IBU 250 mg, APAP 650 mg, or placebo evaluated over 12 hours (study 1) or multiple-dose FDC or placebo every 8 hours, evaluated over 48 hours (study 2). Time-weighted sum of pain intensity differences over 8 (SPID[11]_0-8) and 24 (SPID[11]0-24) hours were primary outcomes, respectively. Time to meaningful pain relief and duration of pain relief were assessed; tolerability was evaluated by adverse events.

RESULTS:

Five hundred sixty-eight patients were randomized in study 1; 123 in study 2. Study 1: SPID[11]_0-8 favored FDC significantly over placebo, IBU, and APAP (P < 0.001, P = 0.008, and P < 0.001, respectively); study 2: SPID[11]_0-24 significantly favored FDC over placebo (P < 0.001), with sustained efficacy during multiple dosing. Time to meaningful pain relief occurred within 1 hour; pain relief duration was > 8 hours in both studies. Adverse event rates were lowest with the FDC.

DISCUSSION:

FDC IBU/APAP 250/500 mg provides superior analgesic efficacy to individual monocomponents (IBU 250 mg and APAP 650 mg), a rapid onset of action, > 8-hour duration of pain relief, is generally well tolerated, and may provide an additional nonopioid treatment option for acute pain. (PsycInfo Database Record (c) 2021 APA, all rights reserved)