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

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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 , 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

S. , 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 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