Monday January 4, 7:01 am Eastern Time
Company Press Release
SOURCE: G.D. Searle & Co.
FDA Approves Celebrex(TM) (celecoxib) For Osteoarthritis and Rheumatoid Arthritis
A New, Important Therapy for Arthritis Patients
CHICAGO, Jan. 4 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Celebrex™ (celecoxib) for relief of the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA). Celebrex will be co-promoted by G.D. Searle & Co., the pharmaceutical business unit of Monsanto Company (NYSE: MTC - news), and Pfizer Inc. (NYSE: PFE - news).
Celebrex is an important treatment alternative for millions of people with arthritis. Celebrex was tested in clinical trials that involved over 13,000 patients and healthy volunteers enrolled in more than 50 different clinical studies in 23 countries worldwide. In clinical trials, Celebrex was shown to be as effective as the prescription-strength nonsteroidal anti-inflammatory drug (NSAID) naproxen in treating arthritis pain and inflammation. In OA patients, Celebrex improved pain, stiffness and patient functions, such as walking, bending and getting in and out of a car. Importantly, Celebrex was associated with significantly fewer upper gastrointestinal (GI) ulcers than both naproxen and another widely used medication, ibuprofen.
Celebrex was designed using advanced molecular technology. Scientists believe that Celebrex works by inhibiting an enzyme called COX-2, which plays a role in pain and inflammation. However, Celebrex, at therapeutic doses, does not inhibit the COX-1 enzyme, which helps maintain the normal stomach lining. NSAIDs in general inhibit both COX enzymes, so they treat pain and inflammation but may damage the stomach lining, potentially leading to ulcers in some patients.
''With the discovery that cyclooxygenase, or 'COX', exists in two distinct forms -- COX-1 and COX-2, we modified our approach to treating arthritis,'' said Philip Needleman, Ph.D., co-president, Searle, and chief scientist, Monsanto. ''Celebrex is an important new therapy that targets arthritis pain and inflammation, but limits certain serious GI side effects associated with existing prescription medications.''
Celebrex, which received priority review from the FDA, will be available by prescription in early 1999. The recommended therapeutic dose of Celebrex for OA is 200 mg daily administered as a single dose or 100 mg twice daily. For RA, the recommended therapeutic dose is 100 mg to 200 mg, twice daily.
Many of the approximately 40 million Americans with arthritis use the currently available NSAIDs. Use of these medications may lead to stomach ulcers and other serious complications, such as GI bleeding or perforation. In fact, a recent study estimates that these complications cause 107,000 hospitalizations and 16,500 deaths each year in the United States.
''Celebrex represents a significant contribution to the treatment of arthritis,'' said Richard U. De Schutter, CEO, Searle, and vice chairman, Monsanto. ''Millions of patients who suffer from this debilitating disease will now have a new option for the relief of their symptoms, with less risk of GI ulceration.''
''Relieving the pain and inflammation of arthritis is very important for patients around the world,'' said Henry A. McKinnell, Ph.D., executive vice president of Pfizer and president, Pfizer Pharmaceuticals Group. ''We expect that Celebrex will address serious unmet medical needs.''
Arthritis is a chronic condition characterized by pain and inflammation of the joints (e.g., knees, hips, fingers, feet, spine and shoulders). The most common type of arthritis, osteoarthritis, is a degenerative joint disease in which cartilage that covers the ends of the bones in the joint deteriorates, causing pain and loss of movement. Rheumatoid arthritis is an autoimmune disease in which the joint lining becomes inflamed as part of excessive immune system activity. Rheumatoid arthritis often results in destruction of the joint, pain and disfigurement, and limits the normal range of motion of the affected joint. Arthritis is estimated to cost the U.S. economy $65 billion per year in medical care and lost wages. Annual costs in the U.S. for hospitalizations resulting from serious NSAID side effects exceed $1 billion.
In clinical studies, the most common GI side effects of Celebrex were dyspepsia, diarrhea and abdominal pain. Discontinuation due to each of these side effects was less than one percent. Patients who have a known allergic reaction to celecoxib, sulfonamides, aspirin or NSAIDs should not use Celebrex. Although Celebrex has a low potential for stomach ulcers, serious GI tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert for signs and symptoms of GI bleeding.
Searle, a global leader in arthritis products and educational programs, is the pharmaceutical sector of Monsanto Company (NYSE:MCT - news; NYSE: MTC - news). Searle develops, produces and markets prescription pharmaceuticals, including major products to treat arthritis, cardiovascular disease, cancer and its complications and insomnia, and to promote women's health. For more information on Searle, access searlehealthnet.com. As a life sciences company, Monsanto is committed to finding solutions to the growing global needs for food and health by sharing common forms of science and technology among agriculture, nutrition and health. In 1997, Monsanto reported sales of $7.5 billion and invested nearly $1 billion in research and development.
Pfizer Inc. (NYSE: PFE - news) is a research-based, global healthcare company. Pfizer discovers and develops innovative, value-added products that improve the quality of life of people around the world and helps them enjoy longer, healthier, and more productive lives. The company has three business segments: health care, animal health, and consumer health care, with products available in more than 150 countries. In 1997, the company reported revenues of $12.5 billion and plans to invest approximately $2 billion in research and development in 1998. For more information on Pfizer, access pfizer.com.
SOURCE: G.D. Searle & Co. |
