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| |  New COX-2 Specific Inhibitor Valdecoxib Compared to Oxycodone/Acetaminophen for Pain Relief After Dental Surgery - Study Results Published in the Journal of the American Dental Association - PEAPACK, NJ -- May 8, 2002 -- Results of two investigational studies published today in the Journal of the American Dental Association show that valdecoxib tablets at doses of 20 mg and 40 mg offers relief for the treatment of pain associated with dental surgery. Valdecoxib showed significantly better pain relief compared to placebo and in a secondary analysis, showed comparable pain relief to oxycodone 10 mg/acetaminophen 1,000 mg. Valdecoxib was recently approved by the U.S. Food and Drug Administration under the brand name BEXTRA and is now widely available for the treatment of osteoarthritis, adult rheumatoid arthritis and primary dysmenorrhea (painful menstrual cramping). Oxycodone 10 mg/acetaminophen 1,000 mg is a narcotic-containing analgesic. "These studies showed that valdecoxib provided relief in a painful post-operative dental model," said lead author and principal investigator Paul J. Desjardins, DMD, PhD, Senior Vice President of Analgesic Research at SCIREX Corporation, headquartered in Austin, Texas. "Many experts agree that the post-operative dental pain model allows for an accurate assessment of pain relief; therefore, these positive investigational results justify further study of valdecoxib in this area." Efficacy Assessments Reductions in pain intensity were measured by improvement from baseline. Higher values indicate an improvement (lessening) of the patient's pain compared with baseline. In both studies, reductions in pain intensity from baseline at one hour for valdecoxib 20 mg (0.85-1.22) and valdecoxib 40 mg (1.12-1.28) were significantly different than placebo (0.10 - 0.27). Also at one hour, the reduction in pain intensity of valdecoxib 40 mg was comparable to oxycodone 10 mg/acetaminophen 1,000 mg (1.40 - 1.45). At five hours, reductions in pain intensity in both studies for valdecoxib 20 mg (1.23-1.57) and valdecoxib 40 mg (1.54 -1.74) were significantly different than placebo (0.22 - 0.25 hr). Also at five hours, reduction in pain intensity for valdecoxib 20 mg and 40 mg were comparable to oxycodone 10 mg/acetaminophen 1,000 (1.18-1.31) in both studies. Common adverse events reported by both treatment groups included dizziness, headache, nausea, vomiting and somnolence (drowsiness), postoperative tissue swelling, nervousness and pharyngitis. The incidence of narcotic-associated adverse events, such as nausea, dizziness and vomiting, were lower in the valdecoxib groups versus the oxycodone 10 mg/acetaminophen 1,000 mg group. Study Design Clinical safety was monitored throughout the study, noting adverse events as well as changes in clinical laboratory testing and physical examination during the 24-hour treatment period and up to the post-treatment visit five to nine days after the end of treatment. Additional Information BEXTRA is contraindicated in patients with known hypersensitivity to valdecoxib. BEXTRA should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or NSAIDs, or who are in their third trimester of pregnancy. As with all NSAIDs, serious GI toxicity can occur with or without warning. Physicians and patients should remain alert to the signs and symptoms of GI bleeding. BEXTRA does not affect platelet function and therefore should not be used for cardiovascular prophylaxis. Rare cases of severe renal and hepatic reactions have been reported with NSAIDs. BEXTRA should be used with caution in patients with fluid retention, hypertension, or heart failure. Patients should tell their doctor if they have liver, kidney, or heart problems. Use of BEXTRA in patients with advanced kidney disease is not recommended. In arthritis clinical studies, the most common side effects were headache, abdominal pain, dyspepsia, upper respiratory tract infection, nausea, and diarrhea. Anticoagulant therapy should be monitored, particularly during the first few weeks, after initiating therapy with BEXTRA in patients receiving warfarin or similar agents. The drug is co-marketed by Pharmacia Corporation and Pfizer Inc. Pharmacia Corporation (NYSE: PHA) is a top-tier global pharmaceutical company with a leading agricultural subsidiary. Pharmacia's innovative medicines and other products save lives and enhance health and wellness. Pharmacia's 59,000 people work together with many diverse stakeholders to bring these benefits to people around the world, and to create new health solutions for the future. Pfizer Inc (NYSE: PFE) discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products. BEXTRA® is a registered trademark of Pharmacia Corporation. For complete prescribing information on BEXTRA, access http://www.pharmacia.com/products/pharm.asp#B or call toll-free 888-4-BEXTRA. This press release contains forward-looking or anticipatory statements about the companies' business and financial performance plans which are based on the information currently available and the expectations currently deemed reasonable by the companies. However, because these forward-looking statements are subject to many risks, uncertainties and changes over time, including those referenced in the companies' filings with the U.S. Securities and Exchange Commission, actual results may differ materially from those expressed or implied by these forward-looking statements. The companies undertake no obligation to update any forward-looking statements as a result of new information or future developments.
Media Contact Analyst Contact SOURCE: Pharmacia Corp
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