title: 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.
authors.affiliation: Jean Brown Research, Salt Lake City, UT, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Christensen
authors.affiliation: Pfizer Consumer Healthcare, Madison, NJ, USA.
authors.forename: Ed
authors.initials: E
authors.lastname: Paluch
authors.affiliation: Former employee of Pfizer Consumer Healthcare, Madison, NJ, USA.
authors.forename: Shyamalie
authors.initials: S
authors.lastname: Jayawardena
authors.affiliation: Optimal Research, Rockville, MD, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Daniels
authors.affiliation: Pfizer Consumer Healthcare, Madison, NJ, USA.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Meeves
mesh_terms: D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D008297:Male; D009288:Naproxen / Q000008:administration & dosage*; D013607:Tablets; D014081:Tooth Extraction / Q000009:adverse effects*; D014098:Toothache / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics; D003692:Delayed-Action Preparations; D013607:Tablets; D009288:Naproxen; D007052:Ibuprofen
keywords: analgesia; dental pain; extended release; ibuprofen; immediate release