Pharmacia Corp. makes the drug, Bextra (valdecoxib), while drug giant Pfizer Inc. is helping to promote it. Bextra is a member of a class of anti-inflammatory drugs known as COX-2 inhibitors, which work by blocking an enzyme called cyclooxygenase 2. These drugs are believed to sidestep the stomach-irritating effects of other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin.
Osteoarthritis is a progressive deterioration in the cartilage of certain joints. Unlike rheumatoid arthritis, which is an inherited autoimmune disease, osteoarthritis results from overuse of joints, and can be a byproduct of strenuous sports, obesity or aging.
Pharmacia said the drug would also be indicated for treating rheumatoid arthritis and menstrual pain.
Approval of Bextra, Pharmacia and Pfizer said, was based upon global clinical trials involving more than 5,000 patients. The companies said the trials showed that a 10-milligram tablet of Bextra taken once daily was as effective for treating osteoarthritis as the commonly prescribed doses of other NSAIDs, including ibuprofen and naproxen.