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BRIDION(R) (sugammadex) Injection - First and Only Selective Relaxant Binding Agent - Approved in European Union
Date:7/29/2008

. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "This is the first major approval of a product from our combination with Organon BioSciences and is a significant achievement for Schering-Plough. This further validates the value of our combination, which closed in November 2007, and is already making a positive contribution to our business."

BRIDION has a rapid onset and, in addition to routine reversal, can be used in critical situations when immediate reversal of rocuronium is needed. In BRIDION clinical studies, the median time to reversal of rocuronium was about three minutes.

A muscle relaxant plays several critical roles in general anesthesia. Anesthesiologists use muscle relaxation to improve surgical conditions and to facilitate intubation and mechanical ventilation. Reversal agents reverse the effects of muscle relaxants, enabling patients to regain normal muscle function sooner and breathe on their own. Current reversal agents are slow and are associated with certain undesirable side effects, including cardiac rhythm disturbances and gastrointestinal and pulmonary side effects.

"The ability to rapidly reverse both moderate and deep levels of muscle relaxation during general anesthesia was not possible before BRIDION," said Rajinder Mirakhur, M.D., professor of anesthetics at The Queen's University of Belfast, Northern Ireland, and a principal investigator in the BRIDION clinical trials program. "BRIDION can provide us with greater flexibility to induce and maintain the level of muscle relaxation with rocuronium or vecuronium necessary throughout surgery and reverse that relaxation quickly when needed."

BRIDION (sugammadex) Clinical Trials

The EC approval of BRIDION is based on an extensive clinical trial database of approximately 1,800 patients and volunteers, including data from the SIGNAL, AURORA and SPECTRUM clinical trials. The SIGNAL trial involved adult patients underg
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SOURCE Schering-Plough Corporation
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