Celebrex (Celecoxib) Once-Daily for Osteoarthritis

Is as Effective as a Twice-Daily Dose

The primary objective of this prospective, randomized, placebo-controlled, double-blind, outpatient study was to compare the efficacy of a once-daily regimen of Celebrex (200 mg QD) to the 100 mg BID regimen in treating the signs and symptoms of OA. Six hundred and eighty-six patients with OA of the knee in a flare state were enrolled in this parallel-group, multicenter study. Patients were randomly assigned to receive Celebrex 100 mg BID, Celebrex 200 mg QD, or placebo for a six-week treatment period. The results show that in all efficacy measures, both doses of Celebrex produced clinical improvement in the signs and symptoms of OA that were superior to those seen with placebo and essentially indistinguishable from each other.

Commenting on the study's significance, Gary W. Williams, M.D., lead author and head of the Division of Rheumatology at the Scripps Clinic, in La Jolla, California said, "We have confirmed that the 200 mg once-daily regimen is effective and safe in treating OA. This offers added convenience and ease for patients who would prefer a once-daily dose."

Physicians' current prescribing behavior is consistent with these findings; 83 percent of physicians prescribing Celebrex are choosing the once-daily regimen.

Celebrex is the first COX-2 specific inhibitor approved by the U.S. Food and Drug Administration for the treatment of osteoarthritis and adult rheumatoid arthritis, and is co-promoted by Searle and Pfizer Inc. Patients who have a known allergic reaction to celecoxib, certain sulfa drugs called sulfonamides, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) should not use Celebrex. As with all NSAIDs, serious gastrointestinal toxicity can occur with or without warning symptoms. In clinical trials, the most common side effects of Celebrex were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate.

Searle, the leading arthritis company worldwide, is the largest provider of branded prescription arthritis medicines in the United States and is the first company to bring COX-2 technology to the marketplace.

Pharmacia Corporation is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn and Monsanto Company with its G.D. Searle & Co. unit. Pharmacia has a broad product portfolio, a robust pipeline of new drugs, and an annual investment of more than $2 billion in pharmaceutical research and development. In its Monsanto subsidiary, Pharmacia has one of the world's leading fully integrated agricultural businesses.