A2 AASHIRWAD, II CROSS LANE, LOKHANDWALA COMPLEX, ANDHERI (WEST), MUMBAI 400053, INDIA

The results from a dose-ranging study conducted by Merck with etoricoxib, ibuprofen, and placebo were presented at the annual meeting of the American Pain Society in Atlanta. Etoricoxib is an investigational medicine under development at Merck that is designed to specifically inhibit the cyclooxygenase-2 (COX-2) enzyme.

The study evaluated 398 patients who had at least two third molars removed. Patients in this randomized single-center, double-blind, placebo-and active-comparator controlled study were allocated to receive single doses of placebo (49 patients) or doses of etoricoxib, 60 mg (75 patients), 120 mg (76 patients), 180 mg (74 patients), 240 mg (76 patients) or ibuprofen 400 mg (48 patients).

Compared to placebo, etoricoxib and ibuprofen resulted in significantly greater total pain relief as reported by patients. Total treatment response was measured by TOPAR8 (total pain relief over 8 hours) and expressed as the average change in the degree of pain relief at specified time periods following the administration of drug.

Based on a 0-to-4 score scale (0 = poor, 4 = excellent), patients' global evaluation of the study medication were 2.1, 2.6, 2.9, 2.7, and 2.3 for doses of etoricoxib and ibuprofen, respectively, compared to 0.5 for placebo at 8 hours after treatment. Furthermore, 64, 83, 89 and 84 percent of patients on doses of etoricoxib, 78 percent of patients on ibuprofen, and 19 percent on placebo evaluated their response to treatment as "good" to "excellent".

The median time to onset of pain relief, determined by the two stop-watch method, was 24 minutes for 120, 180 and 240 mg etoricoxib, 30 minutes for etoricoxib 60 mg and ibuprofen 400 mg and more than four hours with placebo. The duration of pain relief was significantly longer for all doses of etoricoxib and ibuprofen compared to placebo as estimated by the median time to use of rescue medication by patients. Specifically, the median time to rescue medication for etoricoxib 120, 180 and 240 mg was greater than 24 hours, for etoricoxib 60 mg it was approximately 12 hours, for ibuprofen it was approximately 10 hours and for placebo it was approximately two hours.

"Patients in the study experienced significant pain relief with etoricoxib compared to placebo based on several measures, including patients' response to treatment," said Dr. Kerstin Malmstrom, director, Merck Research Laboratories. "In this study, the overall analgesic effect of etoricoxib 120 mg, 180 mg and 240 mg, measured by the degree and duration of pain relief, was also similar to ibuprofen.