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Reference Desk December 2011

FDA Approves DERAMAXX® (deracoxib) Labeling for Dental Surgery Pain Management

    GREENSBORO, North Carolina, December 9, 2011—DERAMAXX® (deracoxib) is now approved by the U.S. Food and Drug Administration for the control of postoperative pain and inflammation associated with dental surgery in dogs.

    In a prospective, randomized, blinded, placebo-controlled, multicenter clinical field study of 62 dogs, DERAMAXX® was shown to be effective for canine dental surgery pain and inflammation.1 Currently, DERAMAXX® is approved for the control of postoperative orthopedic pain and inflammation and for the control of pain and inflammation associated with canine osteoarthritis.

    Study results indicated that perioperative administration of DERAMAXX® to dogs at the low dose of 1–2 mg/kg body weight at least one hour prior to surgery, and again for two more days, effectively managed the pain and inflammation associated with dental surgery in dogs receiving butorphanol as a preanesthetic. A modification of the Glasgow Composite Pain Scale (mGCPS) was used to assess and measure pain prior to surgery and again at regular intervals following dental extractions. In the study, 66.7% of the dogs receiving placebo required additional pain medication, compared with only 14.8% of dogs treated with DERAMAXX®.

    Measuring oral pain in animals is particularly challenging since pain may be masked by the animal and not obvious to an observer. “Tooth extractions can be quite invasive and require pain management both during and after surgery,” said Larry D. Baker, DVM, FAVD, Diplomate AVDC, Northgate Veterinary Dentistry, Decatur, Illinois, and one of the study’s participants. “Results of the study showed that administering DERAMAXX® to dogs at a dose of 1–2 mg/kg per day for three days is well tolerated and significantly improves pain control after dental surgery.”

    The study notes that DERAMAXX® at the recommended dose was shown to be safe in target animal safety studies,2 and clinical experience has shown that, when used as directed, DERAMAXX® is both safe and effective for managing postsurgical orthopedic pain and pain associated with osteoarthritis.

    Safety Information

    As with all drugs in this class, side effects involving the digestive system, kidneys, or liver may occur. These are normally mild, but may be serious. Pet owners should discontinue therapy and contact their veterinarian immediately if side effects occur. Evaluation for preexisting conditions and regular monitoring are recommended for pets on any medication, including Deramaxx. Use with other NSAIDs or corticosteroids should be avoided.  For full product information see www.deramaxx.com.

    About Novartis Animal Health

    Headquartered in Greensboro, NC, Novartis Animal Health US, Inc. researches, develops and commercializes leading animal treatments that meet the needs of pet owners,farmers and veterinarians. Part of the Basel, Switzerland-based Novartis Animal Health global organization, the US business is the largest of the 40 countries where Novartis Animal Health operates. For more information about Novartis Animal Health US, Inc., please consult http://www.ah.novartis.us.

    1Bienhoff S, Smith E, Roycroft L, Roberts E. Efficacy and safety of deracoxib for thecontrol of postoperative pain and inflammation associated with dental surgery in dogs. Data on file, Novartis Animal Health US, Inc.
    2Roberts ES, Van Lare KA, Marable BR, Salminen WF. Safety and tolerability of 3-week and 6-month dosing of Deramaxx® (deracoxib) chewable tablets in dogs. Vet Pharmacol Ther 2009 Aug:32(4):329-37. (First published online Dec. 4, 2008.)


    Source: Novartis Animal Health

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