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April 12, 2002
The newest COX-2 specific inhibitor, Bextra® (valdecoxib), is now available nationwide for the treatment of osteoarthritis (OA), adult rheumatoid arthritis (RA), and the treatment of painful menstrual cramping.
Pharmacia Corporation and Pfizer Inc. today announced the availability of the new medicine, which was approved by the U.S. Food and Drug Administration in late 2001. A once-daily 10 mg dose of Bextra offers 24-hour pain relief for both OA and RA.
"Bextra provides a new option to help millions of patients who need powerful arthritis pain relief," said Gary Williams, MD, PhD, Chairman, Department of Medicine, Scripps Clinic Medical Group, La Jolla, California. "The national availability of Bextra offers physicians a once-daily treatment option which in clinical studies has demonstrated a reduced incidence of endoscopically-detected ulcers compared to ibuprofen, naproxen and diclofenac."
Since February, thousands of patients suffering from arthritis or painful menstrual cramping in the United States have been treated with Bextra through an Early Experience Program. Participating physicians had the opportunity to gain experience with Bextra in their own clinical setting. This week, Bextra will be introduced to primary care physicians, rheumatologists, gastroenterologists, and OB/GYNs.
"We are encouraged by the positive response we have received from physicians and patients through our Early Experience Program," said Carrie S. Cox, Executive Vice President and President, Global Prescription Business, Pharmacia Corporation. "Our COX-2 specific inhibitor portfolio with Celebrex® [celecoxib] and Bextra provides options physicians need to effectively treat arthritis and other painful conditions."
Bextra was well-tolerated with a superior upper GI safety profile. In two large, randomized, three-month studies, the incidence of endoscopically-observed gastroduodenal ulcers was significantly lower for Bextra than the comparator non-steroidal anti-inflammatory drugs (NSAIDs) ibuprofen, diclofenac and naproxen. The correlation between findings of endoscopic studies and the incidence of clinically relevant serious upper GI events has not been established. The most common adverse events were headache, abdominal pain, dyspepsia, upper respiratory infection, nausea and diarrhea.
More than 23 million Americans have some form of arthritis. Among the various forms of arthritis, osteoarthritis is the most prevalent, affecting 21 million Americans. Characterized by the degeneration of joint cartilage and adjacent bone, OA is a chronic disorder that can cause pain and stiffness. Rheumatoid arthritis, which affects more than 2.1 million Americans, is a painful, systemic, autoimmune disease that affects primarily joint lining, cartilage and bones.
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