New COX-2 Specific Inhibitor BEXTRA(R) Compared With Vioxx(R) for Pain Relief In Patients Following Oral Surgery
Investigational Study Results Published in the American Journal of Therapeutics
PEAPACK, N.J., March 25 /PRNewswire-FirstCall/ -- An investigational study of the new COX-2 specific inhibitor BEXTRA® (valdecoxib tablets) published in the March 22nd issue of the American Journal of Therapeutics, evaluated the efficacy and safety of BEXTRA versus Vioxx® (rofecoxib tablets) for the management of moderate to severe post surgical dental pain. BEXTRA was recently approved by the U.S. Food and Drug Administration and is now available for treating the signs and symptoms of osteoarthritis and adult rheumatoid arthritis and primary dysmenorrhea (painful menstrual cramping). However, BEXTRA is not approved for acute pain at this time.
``Post-surgical pain can be undermanaged and cause patients tremendous discomfort,'' said Dr. Steve Geis, Group Vice President of Clinical Research. ``This investigational study suggests that BEXTRA may offer promise in acute pain management and further study is required.''
Study Design
In a double-blind, placebo-controlled parallel group study comparing BEXTRA with Vioxx for postoperative pain relief, 203 patients with moderate or severe pain were randomized to receive BEXTRA 40 mg, Vioxx 50 mg or placebo following oral surgery (extraction of two or more third molars with a minimum of one impaction). After four hours, an optional re-dose was available; patients randomized to BEXTRA received BEXTRA 40 mg, while patients randomized to Vioxx and placebo received placebo(1).
During the surgeries, the only pain medication offered was local anesthetics and inhaled nitrous oxide. After surgery, if patients needed additional pain relief beyond the study medications, ``rescue medications'' of acetaminophen 1,000 mg, hydrocodone 5 mg/acetaminophen 500 mg or hydrocodone 7.5 mg/acetaminophen 500 mg were allowed at any time during the study.
There were three primary efficacy endpoints in this study: the percent of patients experiencing ``failure of regimen'', the percent of patients taking rescue medication, and the change in pain intensity from baseline at 1 hour after the first dose of study drug. Regimen failure was defined in the BEXTRA group as the request for rescue medication. In the groups receiving Vioxx or placebo, regimen failure was defined as the request for either rescue medication or the second dose of study medication. Pain intensity was assessed on a 4-point scale from zero representing no pain to 3 representing severe pain.
Study Results
The percentage of patients who experienced regimen failure was 40 percent in the BEXTRA group, 80.5 percent in the Vioxx group and 92.7 percent in the placebo groups (p<.05). A total of 57 patients, 28 (35 percent) in the BEXTRA group, 26 (32.1 percent) Vioxx group, and three (7.3 percent) in the placebo group took a second dose of blinded study medication. The percentage of patients who required rescue medication was 40 percent in the BEXTRA group, 58.5 percent in the Vioxx group and 92.7 percent in the placebo group (p<.05).
The mean pain intensity difference from baseline at 1 hour was 0.49 for BEXTRA, 0.29 for Vioxx and -0.34 for placebo. Higher values indicate an improvement (lessening) of the patient's pain compared with baseline; negative values indicate worsening of pain. Both active treatments were significantly better than placebo in change in pain intensity at 1 hour, but were not significantly different from each other. At all other time points assessed (from 30 minutes to 24 hours), BEXTRA demonstrated a statistically significant higher score for pain intensity difference compared with Vioxx.
There were no significant differences between the BEXTRA and Vioxx treatments groups in the incidence of adverse events. The most common adverse events were nausea, alveolar osteitis (``dry socket''-pain in and around the tooth extraction site), headache, vomiting, dizziness and pharyngitis (inflammation of the pharynx).
Additional Information
BEXTRA (valdecoxib tablets) is indicated for treating the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA), and primary dysmenorrhea (painful menstrual cramping). The recommended dose for OA and adult RA is 10 mg once daily. For menstrual pain, the recommended dose is 20 mg, administered twice daily as needed.
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. 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 - news) 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 - news) 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.
Vioxx® is a registered trademark of Merck & Co.
For complete prescribing information on BEXTRA, access www.pharmacia.com/products/pharm.asp#B or call toll-free 888-4BEXTRA.
This press release contains forward-looking or anticipatory statements about the Company's business and financial performance plans which are based on the information currently available and the expectations currently deemed reasonable by the Company. However, because these forward-looking statements are subject to many risks, uncertainties and changes over time, including those referenced in the Company's 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 Company undertakes no obligation to update any forward-looking statements as a result of new information or future developments.
(1) Patients in the Vioxx group could only receive a redose of placebo as Vioxx 50 mg is the maximum allowable daily dose for the management of acute pain.
SOURCE: Pharmacia Corporation and Pfizer Inc
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