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    FDA Issues Not-Approvable Letter for Sugammedex

    By Jennifer Huddleston, staff writer     

    In a move that shocked researchers and the anesthesiology community, the U.S. Food and Drug Administration (FDA) on Aug. 1, 2008, issued a not-approvable letter for sugammedex, a selective relaxant binding agent that reverses the effects of neuromuscular blockade caused by the drugs rocuronium and vecuronium. [1]

    Sugammedex reverses the effects of neuromuscular blocking agents (NMBAs), which are muscle relaxants frequently administered during surgery to allow total skeletal muscle relaxation and to permit endotracheal intubation.

    The drug was approved in European Union just two days before the FDA rejected sugammedex.

    “It’s safe to say that we were quite disappointed, especially after having experienced the positive opinion and approval in Europe, as well as in the United States,” said Mary Frances Faraji, a spokeswoman for Schering-Plough, the pharmaceutical giant that purchased the developer of sugammedex, Organon BioSciences NV, in November 2007. “In March, we received unanimous recommendation for approval by the FDA Advisory Committee for Anesthetics and Life Support Drugs.”

    After reviewing 30 Phase I, II and III studies involving more than 2,000 patients, the FDA’s advisory committee voted unanimously on March 11, 2008, that the FDA should approve sugammedex for each of its indicated uses.

    However, in its surprising not-approvable decision, the FDA cited concerns that the drug could cause hypersensitivity and allergic reactions in certain patients, fears that many in the anesthesiology community feel are unfounded.

    “I have never seen an allergic reaction with sugammedex, and I was involved in several studies with the drug,” said Karin Khuenl, M.D., Ph.D., a professor of anesthesia and intensive care medicine at the Medical University of Innsbruck in Austria who is considered one of the world’s principal authorities on the drug. “There are other drugs that cause allergic reactions and they’re used on an everyday basis without people being concerned about them.”

    Others who have studied the drug, including Sorin J. Brull, M.D., understand the FDA’s concern and reluctance to approve sugammedex. [8]

    “We’ve had other drugs that were brought to market with great fanfare and were actually withdrawn within months because of mortality,” said Brull, a professor of anesthesiology at the Mayo Clinic College of Medicine in Jacksonville, Florida, and a member of the executive committee and the board of directors of the Anesthesia Patient Safety Foundation. “In those cases, everybody was blaming the FDA for not doing their due diligence. Now that they seem to be doing their due diligence, everyone’s blaming them for being a stumbling block in the way of progress.”

    Schering-Plough has expressed its commitment to working with the FDA to earn its approval, although it will be at least another year before sugammedex could be available in the U.S.

    “I think the important thing for anesthesiologists to know is that ‘not approvable’ means we have more work to do, but it doesn’t mean it’s never approvable,” said Faraji.

    [1] Vlessides, Michael. “FDA Stunner Leaves Sugammadex Watchers Perplexed.” Anesthesiology News, Volume 34:09. September 2008.
    [2]  “Sugammadex Trials Demonstrate Rapid Recovery From Profound Neuromuscular Blockade During General Anesthesia.” Medical News Today. Oct. 17, 2007.
    [3] Vlessides, Michael. “FDA Stunner Leaves Sugammadex Watchers Perplexed.” Anesthesiology News, Volume 34:09. September 2008.
    [4]  Ibid .
    [5]  Ibid .
    [6]  Ibid .
    [7]  Ibid .
    [8]   Ibid .
    [9]  Ibid .
    [10]  Ibid .
    [11]  Ibid .

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