(401) Analgesic effectiveness of a new, extended-release ibuprofen in postoperative dental pain

Abstract

Analgesic effects of an immediate-release/extended-release (IR/ER) 600 mg formulation of ibuprofen (IBU) with q12h dosing were evaluated in 2 single-center, randomized, double-blind, placebo-controlled dental pain studies (Study 1: single dose, 24-hour study; Study 2: multiple doses, 48-hour study). Subjects aged 16–40 years with at least moderate pain following third molar extraction received single doses of 2 IBU 600 mg IR/ER formulations (A or B), naproxen sodium (NAP) 220 mg, or placebo (2:2:2:1 ratio) in Study 1; 4 doses IBU 600 mg IR/ER or placebo (1:1 ratio) in Study 2. Primary efficacy: Study 1, time-weighted sum of pain intensity difference (SPID) scores from 0–12 and 8–12 hours; Study 2, time-weighted sum of pain relief and pain intensity differences (SPRID) from 0–12 and 8–12 hours. In Study 1 (N=196), mean (standard deviation [SD]) SPID 0–12 scores were 0.05 (9.2), 16.87 (9.4), 17.34 (10.5), and 12.66 (10.0) and mean (SD) SPID 8–12 scores were -0.03 (4.1), 6.57 (4.4), 7.14 (5.2), and 5.14 (5.0) for placebo, IBU IR/ER A, IBU IR/ER B, and NAP, respectively (P<0.001, all comparisons vs placebo). In Study 2 (N=106), mean (SD) SPRID 0–12 scores were 18.2 (20.0) vs 41.5 (21.0) and mean (SD) SPRID 8–12 scores were 10.3 (12.0) vs 18.4 (12.1) for placebo and IBU IR/ER, respectively (P<0.001, both favoring IBU IR/ER). SPID score separation from placebo at predefined intervals was maintained throughout the 48-hour study, except for the 20- to 24-hour interval. Significantly more AEs occurred with placebo in Study 1 (P=0.045) and Study 2 (P=0.001); gastrointestinal AEs predominated in subjects receiving placebo, likely due to opioid rescue medication use. No serious AEs occurred. IBU 600 mg IR/ER administered every 12 hours provided safe and effective analgesia following both single and multiple doses. Supported by Pfizer Consumer Healthcare. Analgesic effects of an immediate-release/extended-release (IR/ER) 600 mg formulation of ibuprofen (IBU) with q12h dosing were evaluated in 2 single-center, randomized, double-blind, placebo-controlled dental pain studies (Study 1: single dose, 24-hour study; Study 2: multiple doses, 48-hour study). Subjects aged 16–40 years with at least moderate pain following third molar extraction received single doses of 2 IBU 600 mg IR/ER formulations (A or B), naproxen sodium (NAP) 220 mg, or placebo (2:2:2:1 ratio) in Study 1; 4 doses IBU 600 mg IR/ER or placebo (1:1 ratio) in Study 2. Primary efficacy: Study 1, time-weighted sum of pain intensity difference (SPID) scores from 0–12 and 8–12 hours; Study 2, time-weighted sum of pain relief and pain intensity differences (SPRID) from 0–12 and 8–12 hours. In Study 1 (N=196), mean (standard deviation [SD]) SPID 0–12 scores were 0.05 (9.2), 16.87 (9.4), 17.34 (10.5), and 12.66 (10.0) and mean (SD) SPID 8–12 scores were -0.03 (4.1), 6.57 (4.4), 7.14 (5.2), and 5.14 (5.0) for placebo, IBU IR/ER A, IBU IR/ER B, and NAP, respectively (P<0.001, all comparisons vs placebo). In Study 2 (N=106), mean (SD) SPRID 0–12 scores were 18.2 (20.0) vs 41.5 (21.0) and mean (SD) SPRID 8–12 scores were 10.3 (12.0) vs 18.4 (12.1) for placebo and IBU IR/ER, respectively (P<0.001, both favoring IBU IR/ER). SPID score separation from placebo at predefined intervals was maintained throughout the 48-hour study, except for the 20- to 24-hour interval. Significantly more AEs occurred with placebo in Study 1 (P=0.045) and Study 2 (P=0.001); gastrointestinal AEs predominated in subjects receiving placebo, likely due to opioid rescue medication use. No serious AEs occurred. IBU 600 mg IR/ER administered every 12 hours provided safe and effective analgesia following both single and multiple doses. Supported by Pfizer Consumer Healthcare.