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Bextra (Valdecoxib) Now Widely Available in U.S. for Arthritis Pain/Inflammation and Menstrual Cramping

PEAPACK, NJ -- April 10, 2002 -- The newest COX-2 specific inhibitor, Bextra® (valdecoxib tablets), is now available nationwide for the treatment of the signs and symptoms 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.

For menstrual pain, the recommended dose of Bextra is 20 mg, administered twice daily as needed.

"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."

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.

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 is the second drug to emerge from the Pharmacia/Pfizer COX-2 Franchise, preceded by Celebrex, the world's first COX-2 specific inhibitor and the most widely prescribed arthritis medication. Both drugs are co-promoted by Pharmacia Corporation and Pfizer Inc.

"The launch of Bextra allows us to build upon the success of Celebrex and further establish the role of COX-2 specific inhibitors in the management of arthritis pain," said Karen Katen, President of the Global Pfizer Pharmaceuticals Group, and Executive Vice President, Pfizer Inc. "The availability of these two products clearly establishes our leadership role in this market."

Bextra is available only by prescription. Retail pharmacies began stocking Bextra during the first quarter of 2002. Bextra is packaged in bottles containing 100 10 mg or 20 mg dose tablets.

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.

Bextra and Celebrex should not be given to patients who are in their third trimester of pregnancy (as they may increase the risk of premature closure of the ductus arteriosus). In addition, Bextra and Celebrex should not be given to patients who have experienced asthma, urticaria (hives) or allergic-type reactions after taking aspirin, or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to Bextra and Celebrex are possible in such patients. Like all NSAIDs, Bextra and Celebrex should be used with caution in patients with fluid retention, hypertension, or heart failure. Patients should tell their doctor if they have liver or kidney problems.
In addition, Celebrex should not be given to patients who have demonstrated allergic-type reactions to sulfonamides. In overall clinical studies, the most common side effects of Celebrex were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate.

As with all NSAIDs, serious GI ulcerations can occur without warning symptoms. Physicians and patients should remain alert to the signs and symptoms of GI bleeding.

Bextra and Celebrex do not affect platelet function and therefore should not be used for cardiovascular prophylaxis.

SOURCE: Pharmacia Corporation; Pfizer Inc

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