Results of this study were presented here today at the 19th Annual Meeting of the American Pain Society. The study compared a single dose of Vioxx 50 mg, the recommended dose for the treatment of acute pain in adults, to a single dose of codeine 60 mg with acetaminophen 600 mg, and to placebo. For acute pain, Vioxx 50 mg is dosed once-daily, as needed. The study evaluated pain relief using a number of measures. This new study is the first to compare the efficacy and safety of Vioxx to codeine with acetaminophen, a medicine commonly prescribed by dentists and oral surgeons to relieve pain after dental surgery.
Additional studies are underway.
Overall, Vioxx was well tolerated in this study, and the overall rate of side effects on Vioxx was generally similar to placebo. In particular, nausea and vomiting occurred less frequently in patients taking Vioxx than in patients taking codeine with acetaminophen. There were no serious adverse events in any treatment group. Vioxx is approved in the United States for the relief of the signs and symptoms of osteoarthritis, management of acute pain in adults and treatment of menstrual pain. The recommended dose of Vioxx for the treatment of osteoarthritis is 12.5 mg once daily.