The study investigated the effects of FDCs (fixed-dose combinations) of ibuprofen/acetaminophen (IBU/APAP) for post-surgical dental pain depicted that each of the tested FDCs provided analgesia that was similar to that with IBU 400 mg and superior to that with placebo. Each FDC provided MPR (meaningful pain relief) in < 1h, and duration of pain relief > 9 h. All the FDCs were generally well-tolerated, with an adverse event profile similar to that of both placebo and IBU 400mg.

The phase II, 12-h, double-blind, five-arm, parallel-group, in-patient, placebo-controlled study aimed to examine the overall analgesic efficacy of three different FDCs of IBU/APAP compared with IBU 400 mg and placebo for post-surgical dental pain.

A total of 576 patients were screened, and 394 patients were randomized. In patients with moderate-to-severe pain following third molar extraction, the study compared three FDCs of IBU/APAP (200 mg/500 mg, 250 mg/500 mg, and 300 mg/500 mg) with IBU 400 mg and placebo. The primary efficacy endpoint measured was SPRID[4]0–8 (time-weighted sum of pain relief and pain intensity difference scores from 0 to 8 h after dosing). The duration of pain relief, AEs (adverse events), TMPR (Time to meaningful pain relief) were also estimated.

All the active treatments were found to be superior to placebo for SPRID[4]0–8  but not significantly different from ibuprofen 400 mg. The median TMPR with the FDCs IBU/APAP formulations ranged from 44.5 to 54.1 minutes compared with 56.2 min with IBU 400 mg and >720 min with placebo.

The median time to treatment failure with placebo was 1.6 h, whereas a similar median time to treatment failure was found with all the three FDCs (9.7, 10.1, and 11.1 h). Results for the FDCs were not considerably different from IBU 400 mg (10.4 h) as depicted in Table 1:

Table 1: Median Time to meaningful pain relief and  treatment failure for the groups

The overall incidence of AE was comparable among all the treatment groups.

For postsurgical dental pain, the FDCs of IBU/APAP has a safety and efficacy profile comparable to that of IBU 400 mg.