Sugammadex Study First to Show Rapid Reversal of Profound Rocuronium-Induced Muscle Relaxation i... (ere reported in the study. Text of th...)

Sugammadex Study First to Show Rapid Reversal of Profound Rocuronium-Induced Muscle Relaxation is Possible

Date:10/28/2008

ere reported in the study.

Text of the full study titled, "Reversal of Profound Rocuronium-induced Blockade with Sugammadex: A Randomized Comparison with Neostigmine," can be found on the Anesthesiology website at http://www.anesthesiology.org.

Important Safety Information about BRIDION

BRIDION (sugammadex) was approved for marketing by the European Commission in July 2008. BRIDION should only be administered by or under the supervision of an anesthesiologist. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. The use of BRIDION in patients with severe renal impairment is not recommended.

In clinical trials, the most commonly reported adverse reaction was metal or bitter taste. Also commonly reported were anesthetic complications, indicative of the restoration of neuromuscular function, including movement of a limb or the body or coughing during the anesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube. In a few individuals, allergic-like reactions (i.e. flushing, erythematous rash) following sugammadex were reported.

Status of Sugammadex New Drug Applications

In the United States, the U.S. Food and Drug Administration (FDA) in July 2008 issued a "not-approvable" letter for sugammadex for the reversal of muscle relaxation during general anesthesia. This action was taken by FDA despite a unanimous recommendation for approval by the FDA Advisory Committee on Anesthetics and Life Support in March 2008. Schering-Plough plans to work with the agency to address the issues, which are primarily related to hypersensitivity/allergic reactions, and remains committed to bringing this important medical advance to those who are waiting for it in the United States.

In Japan, a New Drug Application seeking marketing approval of sugammadex has been filed with the Ja
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