Analgesic Efficacy of a New Immediate-Release/Extended-Release Formulation of Ibuprofen: Results From Single- and Multiple-Dose Postsurgical Dental Pain Studies

Abstract

Analgesic effects of ibuprofen immediate-release/extended-release (IR/ER) 600-mg tablets were evaluated in 2 randomized, double-blind, placebo-controlled dental pain studies. Patients 16-40 years old with moderate-severe pain following third-molar extraction received single-dose ibuprofen 600 mg IR/ER (formulation A or B), naproxen sodium 220 mg, or placebo (2:2:2:1; study 1) or 4 doses of ibuprofen 600 mg IR/ER (formulation A) or placebo (1:1; study 2). In study 1 (n = 196), mean (standard deviation [SD]) time-weighted sum of pain intensity difference scores for placebo, ibuprofen IR/ER A, ibuprofen IR/ER B, and naproxen, respectively, were 0.05 (9.2), 16.87 (9.4), 17.34 (10.5), and 12.66 (10.0) over 0-12 hours and -0.03 (4.1), 6.57 (4.4), 7.14 (5.2), and 5.14 (5.0) over 8-12 hours (all P < .001 vs placebo). In study 2 (n = 106), mean (SD) time-weighted sum of pain relief and pain intensity difference scores were 18.2 (20.0) versus 41.5 (21.0) at 0-12 hours and 10.3 (12.0) versus 18.4 (12.1) at 8-12 hours for placebo versus ibuprofen IR/ER, respectively (P < .001 for both); efficacy was sustained over each of the four 12-hour dosing intervals with ibuprofen. Gastrointestinal adverse events predominated with placebo both after study medication administration and after rescue medication use, if applicable. Ibuprofen 600 mg IR/ER provided safe and effective analgesia after single and multiple doses.

Keywords: analgesia; dental pain; extended release; ibuprofen; immediate release.

Figure 1

Study 1 — single‐dose efficacy of 2 formulations of ibuprofen 600 mg IR/ER compared with placebo and naproxen, mean pain intensity difference (PID) scores. A higher score indicates a greater reduction in pain intensity. P < .05 versus placebo for all active treatments at all times starting at first assessment (15 minutes). ER, extended release; IR, immediate release.

Figure 2

Study 1 — single‐dose efficacy of 2 formulations of ibuprofen 600 mg IR/ER compared with placebo and naproxen, mean (SE) SPID 0–12 and SPID 8–12 (coprimary outcomes). ER, extended release; IR, immediate release; SE, standard error; SPID, time‐weighted sum of pain intensity difference. ^a P < .001 versus placebo.

Figure 3

Kaplan‐Meier curve for time to confirmed first perceptible relief in (A) study 1 (single‐dose study) and (B) study 2 (multiple‐dose study). Note: X‐axis is truncated to 2.5 hours. No events occurred later than 2.5 hours. ER, extended release; IR, immediate release. ^a P < .001.

Figure 4

Study 2 — multiple‐dose efficacy of ibuprofen 600 mg IR/ER every 12 hours compared with placebo, mean (SE) sum of pain relief and pain intensity difference (SPRID) scores at 0–12 and 8–12 hours (primary efficacy analyses). ER, extended release; IR, immediate release; SE, standard error. ^a P < .001.

Figure 5

Study 2 — multiple‐dose efficacy of ibuprofen 600 mg IR/ER every 12 hours compared with placebo, mean pain intensity difference (PID) scores. A higher PID score indicates greater reduction in pain intensity. PID scores were significantly (P < .05) greater for ibuprofen IR/ER than for placebo at all assessments except hours 12, 24, 36, and 48 (ie, the end of each dosing interval). Arrows denote dosage administration. ER, extended release; IR, immediate release.