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"The introduction of BRIDION in Europe represents an important advance foranesthesiologists and the patients they care for during surgery, and is asignificant achievement for Schering-Plough, as we bring our first product tomarket since combining with Organon BioSciences," said Fred Hassan, chairmanand CEO. "BRIDION has the potential to transform the practice of anesthesia,and it is a tremendous example of our company's innovation and leadership inthis field."
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BRIDION was discovered by researchers at the company's facility inNewhouse, Scotland, and was approved for marketing by the European Commissionon July 29. It is the first and only selective relaxant binding agent (SRBA)and represents the first major pharmaceutical advance in the field ofanesthesia in two decades. BRIDION is indicated for routine reversal of thecommonly used muscle relaxants rocuronium or vecuronium and for immediatereversal of rocuronium in adults, and for routine reversal followingrocuronium in children and adolescents (2-17 years of age). Rocuronium andvecuronium are given as part of general anesthesia to relax a patient'smuscles during surgery.
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.
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 slow andare associated with certain undesirable side effects, including cardiac rhythmdisturbances and gastrointestinal and pulmonary side effects.
Schering-Plough acquired BRIDION (sugammadex) through its combination withOrganon BioSciences in November 2007.
Important Safety Information About BRIDION
BRIDION (sugammadex) should only be administered by or under thesupervision of an anesthesiologist. The use of an appropriate neuromuscularmonitoring technique is recommended to monitor the recovery of neuromuscularblockade. The use of sugammadex in patients with severe renal impairment isnot recommended.
In clinical trials, the most commonly reported adverse reaction was metalor bitter taste. Also commonly reported were anesthetic complications,indicative of the restoration of neuromuscular function, including movement ofa limb or the body or coughing during the anesthetic procedure or duringsurgery, grimacing, or suckling on the endotracheal tube. In a fewindividuals, allergic-like reactions (i.e. flushing, erythematous rash)following sugammadex were reported.
For full Prescribing Information please go to www.bridion.com.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global healthcare company. Through its own biopharmaceutical research and collaborationswith partners, Schering-Plough creates therapies that help save and improvelives around the world. The company applies its research-and-development
