Vioxx (rofecoxib)

Vioxx is a nonsteroidal anti-inflammatory drug that inhibits cyclooxygenase-2 (COX-2). The COX-2 enzyme controls the conversion of arachidonic acid into prostaglandin E2, a hormone that produces inflammation.

Vioxx has most recently been approved for the relief of the signs and symptoms of rheumatoid arthritis in adults. The drug was initially approved in 1999 for the relief of osteoarthritis, the management of acute pain in adults, and the treatment of primary dysmenorrhea (menstrual pain).

Vioxx is available as a tablet or in a liquid formulation.

UPDATED: WITHDRAWN OCTOBER 2004

Rheumatoid Arthritis

Vioxx was evaluated as an effective treatment for rheumatoid arthritis (RA) in two 12-week, placebo- and active-controlled trials that included approximately 2,000 subjects. Results demonstrated that Vioxx was superior to a placebo in the following measurements: number of tender joints, number of swollen joints, and patient and physician global assessments of disease activity. Additionally, Vioxx was more effective than placebo according to the American College of Rheumatology 20% (ACR20) Responder Index. In terms of the active control, Vioxx 25 mg once daily was generally similar to naproxen 500 mg twice daily in the treatment of RA.

Osteoarthritis

Vioxx was evaluated in placebo- and active-controlled trials for the treatment of osteoarthritis (OA) of the knee and hip. The trials enrolled approximately 3,900 OA subjects and were six to 86 weeks in duration. Treatment with Vioxx 12.5 mg and 25 mg once daily produced improvement in patient and physician global assessments and in the WOMAC (Western Ontario and McMaster Universities) osteoarthritis questionnaire. In all OA clinical studies, once-daily treatment in the morning with Vioxx 12.5 mg and 25 mg was associated with a significant reduction in joint stiffness upon first awakening in the morning. Additionally, Vioxx (at 12.5 mg and 25 mg doses) was shown to be comparable to ibuprofen 800 mg TID and diclofenac 50 mg TID in the treatment of the signs and symptoms of OA.

Analgesia/Pain Relief (including Dysmenorrhea)

Vioxx was shown to relieve pain in acute analgesic models of post-operative dental pain, post-orthopedic surgical pain, and primary dysmenorrhea. The effect of a single 50-mg dose of Vioxx in providing pain relief was generally similar to 550 mg of naproxen sodium or 400 mg of ibuprofen. A single 50-mg dose of Vioxx produced an onset of pain relief within 45 minutes in single-dose post-operative dental pain studies. In a multiple-dose study of post-orthopedic surgical pain, subjects received Vioxx or a placebo for up to five days. Study results demonstrated that 50 mg of Vioxx once daily was effective in reducing pain, and Vioxx-treated subjects took a significantly smaller amount of additional pain medication than subjects treated with placebo.

Side effects reported with Vioxx have included (but are not limited to) the following:

• Upper respiratory infection
• Headache
• Dizziness
• Diarrhea
• Nausea
• Heartburn
• Hypertension
• Back pain
• Tiredness
• Urinary tract infection

Additionally, rare but serious side effects have been reported in patients receiving Vioxx and/or related medications. These include stomach problems, such as stomach and intestinal bleeding, heart attacks, allergic reactions and skin reactions.

Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of Vioxx is believed to be due to inhibition of prostaglandin synthesis, via inhibition of cyclooxygenase-2 (COX-2). At therapeutic concentrations in humans, Vioxx does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme. (from Vioxx Prescribing Information)

For additional information on Vioxx, please visit the product web site at www.vioxx.com.