Efficacy and tolerability of the cyclooxygenase‐2 inhibitor L‐791,515 compared with ibuprofen in patients with postoperative dental pain

Background L‐791,515 ( L )[(5S)‐5‐ethyl‐3‐isopropoxy‐5‐methyl‐4‐[4‐(methylsulfonyl)phenyl]furan‐2(5 H )‐one] is a selective cyclooxygenase‐2 inhibitor investigated for treatment of acute pain and inflammation. Methods This single‐dose, randomized, double‐blind, double‐dummy, placebo‐controlled, parallel‐group study compared L 12.5, 50, and 100 mg with ibuprofen 400 mg or placebo in patients who experienced moderate‐to‐severe pain after surgical removal of≥ 2 third molars. Overall analgesic effect, duration of effect, time to onset of analgesic effect, peak analgesic effect, and tolerability were assessed over a 24‐hour postdose period. Results The study included 121 patients (mean age, 23 years); 16, 31, 28, 31, and 15 patients enrolled in the placebo, L 12.5 mg, L 50 mg, L 100 mg, and ibuprofen 400 mg groups, respectively. Both L 50 and 100 mg were significantly more effective than placebo for all parameters (p <0.01) and comparable to ibuprofen 400 mg. The onset of analgesic effect in the L 50‐mg and 100‐mg, and ibuprofen 400‐mg groups did not differ significantly from each other (p>0.20). L was generally well tolerated in single doses up to 100 mg. Conclusions L 50 and 100 mg were efficacious in the treatment of postoperative dental pain and were indistinguishable from the active comparator, ibuprofen 400 mg. Clinical Pharmacology & Therapeutics (2005) 77 , P52–P52; doi: 10.1016/j.clpt.2004.12.091