MEDINDIA
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BRIDION works in an entirely novel way by encapsulating the musclerelaxant molecule and rendering it inactive. It was specifically designed toreverse within minutes both moderate and deep muscle relaxation induced byrocuronium or vecuronium during general anesthesia. As a result, BRIDION cangive anesthesiologists greater control in managing the depth of musclerelaxation through to the end of a surgical procedure. This may help improvesurgical conditions in the millions of procedures where these agents are used.
"This approval of BRIDION represents the first advance in two decades foranesthesiologists and their patients, and has the potential to transform thepractice of anesthesia," said Thomas P. Koestler, Ph.D., executive vicepresident and president of Schering-Plough Research Institute. "This is thefirst major approval of a product from our combination with OrganonBioSciences and is a significant achievement for Schering-Plough. Thisfurther 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 beused in critical situations when immediate reversal of rocuronium is needed.In BRIDION clinical studies, the median time to reversal of rocuronium wasabout three minutes.
A muscle relaxant plays several critical roles in general anesthesia.Anesthesiologists use muscle relaxation to improve surgical conditions and tofacilitate intubation and mechanical ventilation. Reversal agents reverse theeffects of muscle relaxants, enabling patients to regain normal musclefunction sooner and breathe on their own. Current reversal agents are slowand are associated with certain undesirable side effects, including cardiacrhythm disturbances and gastrointestinal and pulmonary side effects.
"The ability to rapidly reverse both moderate and deep levels of musclerelaxation during general anesthesia was not possible before BRIDION," saidRajinder Mirakhur, M.D., professor of anesthetics at The Queen's University ofBelfast, Northern Ireland, and a principal investigator in the BRIDIONclinical trials program. "BRIDION can provide us with greater flexibility toinduce and maintain the level of muscle relaxation with rocuronium orvecuronium necessary throughout surgery and reverse that relaxation quicklywhen needed."
BRIDION (sugammadex) Clinical Trials
The EC approval of BRIDION is based on an extensive clinical trialdatabase of approximately 1,800 patients and volunteers, including data fromthe SIGNAL, AURORA and SPECTRUM clinical trials. The SIGNAL trial involvedadult patients undergoing surgery. Rocuronium was administered at a standarddose to allow intubation, followed by maintenance doses as required. When 1-2post-tetanic counts (PTC) were observed following neuromuscular stimulation(deep block), patients were administered either sugammadex or neostigmine plusglycopyrrolate, a current reversal regimen. In the SIGNAL trial, the mediantime to reversal of muscle relaxation to a train-of-four (TOF) ratio of 0.9occurred in 2.7 minutes in the suga
