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Powerful Nonnarcotic Analgesic Cleared By FDA PHILADELPHIA, PA -- July 16, 1997 -- Duract(TM) (bromfenac sodium capsules), a potent nonnarcotic analgesic that belongs to the nonsteroidal anti-inflammatory drug (NSAID) class, was cleared for marketing yesterdayby the U.S. Food and Drug Administration (FDA), said Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, announced today. The availability of Duract(TM) marks an important development for health care providers whose patients need fast-acting and powerful relief from acute pain, but want to avoid many of the performance-impairing side effects that can accompany a narcotic opioid analgesic. "This new medication should be a welcome relief for people whose activities have been compromised by acute pain," says Marc W. Deitch, M.D., Senior Vice President, Medical Affairs and Medical Director for Wyeth-Ayerst Laboratories. "Duract(TM) (bromfenac sodium capsules) can provide pain sufferers significant relief from their pain without the combined worry of opioid side effects and the potential for chemical dependency." Today's FDA marketing clearance follows a series of clinical studies that demonstrate the effectiveness of Duract in the management of acute pain in a wide range of applications, such as postoperative use following major abdominal, gynecologic, oral, or orthopedic surgery. The most frequent complaints with Duract(TM) use relate to minor gastrointestinal problems. In some patients treated with Duract, serious gastrointestinal toxicity such as perforation, ulceration, and bleeding can occur. In addition, elevations of liver enzymes have been reported. Therefore, while Duract(TM) is indicated for the short-term management of pain, generally less than 10 days duration, if a physician chooses to administer Duract for a longer duration, it is recommended that liver enzymes should be monitored in patients treated for more than four weeks. More information on: Wyeth-Ayerst Laboratories, More information on: American Home Products Corporation E-mail this page to a friend or colleague! To print, use this version