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    FDA Approves First Injectable Form of Ibuprofen

    By Jennifer Huddleston, staff writer     

    The United States Food and Drug Administration (FDA) on June 11, 2009, approved Caldolor, the first-ever injectable form of ibuprofen for the treatment of acute pain and the reduction of fever in hospitalized patients.

    The drug, manufactured by Tennessee-based Cumberland Pharmaceuticals Inc., may be administered in 400- to 800-milligram doses over 30 minutes, every six hours, to treat acute pain and in a 400-milligram dose over 30 minutes, followed by another 400-milligram dose every four to six hours (or 100 to 200 milligrams every four hours), as needed, to treat fever.
    [1]

    In a statement from the FDA, Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research, said, “Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options. But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”
    [2]

    Currently, the only injectable medications available to treat pain are opioids, many of which can cause undesirable side effects, including nausea, vomiting and sedation, and a non-steroidal anti-inflammatory drug called ketorolac that is associated with an elevated risk of bleeding and gastrointestinal and renal complications.
    [3]

    "We are delighted to obtain FDA approval for the first and only intravenous treatment for pain and fever in the U.S. market," A.J. Kazimi, chief executive officer for Cumberland Pharmaceuticals, said in a press release from the company. "We believe Caldolor represents a significant addition to our product portfolio and a substantial market opportunity." [4]

    Clinical trials involving 1,400 hospitalized patients demonstrated Caldolor’s efficacy and safety in treating pain and fever. In one clinical trial of 319 women who underwent an elective abdominal hysterectomy, patients who were given Caldolor were less likely to ask for morphine to treat their pain. [5] In other trials both critically ill and non-critically ill patients who received Caldolor showed a reduction in fever compared to those who received a placebo. [6]

    While no serious adverse reactions during the trials were attributed directly to Caldolor, the most common adverse reactions reported were nausea, flatulence, vomiting and headache. According to the FDA, the drug has also been associated with high blood pressure and serious skin and allergic reactions. [7]

    The FDA emphasized that the drug should be used with caution in patients with congestive heart failure or renal impairment, those at risk for blood clots and those with a history of ulcers or gastrointestinal bleeding. For those patients, the agency recommends using the lowest effective dose for the shortest amount of time in order to avoid negative outcomes. [8]

    According to Cumberland Pharmaceuticals, which specializes in developing and marketing branded prescription products for hospital acute care, gastroenterology and other targeted physician segments, in 2008 the market for injectable pain relievers was approximately 679 million units in the U.S. alone. Caldolor is the third drug in Cumberland’s portfolio and the company’s second drug to complete development and receive FDA approval.
    [9]

    Caldolor is expected to be available by the end of 2009.


    [1] Riley, Karen. “FDA Approves Injectable Form of Ibuprofen.” FDA News Release. FDA.gov. June 11, 2009.
    [2]  Ibid.
    [3] Cumberland Pharmaceuticals. “Cumberland Pharmaceuticals Announces FDA Approval of Caldolor(TM).” Cumberland Pharmaceuticals Press Release. PR Newswire. June 11, 2009.
    [4]  Ibid
    [5] Riley, Karen. “FDA Approves Injectable Form of Ibuprofen.” FDA News Release. FDA.gov. June 11, 2009.
    [6] Cumberland Pharmaceuticals. “Cumberland Pharmaceuticals Announces FDA Approval of Caldolor(TM).” Cumberland Pharmaceuticals Press Release. PR Newswire. June 11, 2009.
    [7] Riley, Karen. “FDA Approves Injectable Form of Ibuprofen.” FDA News Release. FDA.gov. June 11, 2009.
    [8]  Ibid.
    [9] Cumberland Pharmaceuticals. “Cumberland Pharmaceuticals Announces FDA Approval of Caldolor(TM).” Cumberland Pharmaceuticals Press Release. PR Newswire. June 11, 2009. 



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