US FDA Approves New COX-2 Arthritis Drug

January 1, 2002

By Ori Twersky

WASHINGTON, Nov 19 (Reuters Health) - The US Food and Drug Administration

(FDA) has approved a new drug for treating osteoarthritis, the drug's maker

announced Monday.

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.

Pharmacia spokesman Craig Buchholtz told Reuters Health that the exact

launch date and price per dose had yet to be determined.

The companies estimated that more than 23 million Americans suffer from

arthritis, including the 2.1 million Americans with rheumatoid arthritis.

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