Schering-Plough launches Bridion (sugammadex) in Europe

Schering-Plough Corporation has announced that the European launch of Bridion (sugammadex) injection has begun with its introduction this week in Sweden, and that the product is expected to be available soon in the United Kingdom and Germany, with several other European markets to follow by the end of the year and in early 2009.

"The introduction of Bridion in Europe represents an important advance for anesthesiologists and the patients they care for during surgery, and is a significant achievement for Schering-Plough, as we bring our first product to market since combining with Organon BioSciences," said Fred Hassan, chairman and CEO. "Bridion has the potential to transform the practice of anesthesia, and it is a tremendous example of our company's innovation and leadership in this field."

Bridion was discovered by researchers at the company's facility in Newhouse, Scotland, and was approved for marketing by the European Commission on July 29. It is the first and only selective relaxant binding agent (SRBA) and represents the first major pharmaceutical advance in the field of anesthesia in two decades. Bridion is indicated for routine reversal of the commonly used muscle relaxants rocuronium or vecuronium and for immediate reversal of rocuronium in adults, and for routine reversal following rocuronium in children and adolescents (2-17 years of age). Rocuronium and vecuronium are given as part of general anesthesia to relax a patient's muscles during surgery.

Bridion works in an entirely novel way by encapsulating the muscle relaxant molecule and rendering it inactive. It was specifically designed to reverse within minutes both moderate and deep muscle relaxation induced by rocuronium or vecuronium during general anesthesia. As a result, Bridion can give anesthesiologists greater control in managing the depth of muscle relaxation through to the end of a surgical procedure. This may help improve surgical 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 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.

Schering-Plough acquired Bridion (sugammadex) through its combination with Organon BioSciences in November 2007.

Bridion (sugammadex) 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 sugammadex 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.