This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.
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 250mg/500mg formulation. METHOD(S): 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 250mg/500mg, IBU 250mg, APAP 650mg, 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 (TMPR) and duration of pain relief were assessed; tolerability was evaluated by adverse events (AEs). RESULT(S): 568 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. TMPR occurred within 1 hour; pain relief duration was >8 hours in both studies. AE rates were lowest with the FDC. DISCUSSION: FDC IBU/APAP 250mg/500mg provides superior analgesic efficacy to individual monocomponents (IBU 250mg and APAP 650mg), 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.
<b>OBJECTIVES: </b>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.<b>MATERIALS AND METHODS: </b>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.<b>RESULTS: </b>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.<b>DISCUSSION: </b>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.
This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.
