Fixed-dose ibuprofen–acetaminophen combo a viable nonopioid option for acute pain

Fixed-dose combination of ibuprofen (IBU) and acetaminophen (APAP) produces better analgesic effects compared with either drug alone, as the combination acts rapidly, relieves pain for >8 hours, and is well tolerated, a study has shown.

Researchers examined data from two phase III dental pain studies involving healthy young patients who had moderate-to-severe pain after ≥3 molar extractions. The patients had received a single-dose fixed-dose combination of IBU/APAP 250 mg/500 mg (FDC), IBU 250 mg, APAP 650 mg, or placebo. Effects were evaluated over 12 hours (trial 1) or over 48 hours (trial 2).

A total of 568 patients were included in trial 1 and 123 in trial 2. The primary outcomes were time-weighted sum of pain intensity differences over 8 (SPID[11]0–8) and 24 (SPID[11]0–24) hours, respectively. Other assessments were time to meaningful pain relief (TMPR), duration of pain relief and tolerability.

In trial 1, results for SPID[11]0–8 significantly favoured FDC over placebo, IBU and APAP (p<0.001, p=0.008 and p<0.001, respectively). The same was true in trial 2, where FDC produced greater improvements in SPID[11]0–24 compared with placebo (p<0.001), in addition to having sustained efficacy during multiple dosing.

FDC demonstrated a rapid onset of action, with TMPR occurring within 1 hour of administration. Pain relief duration was >8 hours in both trials.

In terms of safety, FDC was well tolerated. The rates of adverse events were lowest with the combination.