Schering-Plough Corporation announced that the European Commission (EC) has approved Bridion (sugammadex) injection, the first and only Selective Relaxant Binding Agent (SRBA) and the first major pharmaceutical advance in the field of anesthesia in two decades
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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, and are marketed in Europe under the trade names Esmeron and Norcuron, respectively.
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 anaesthesiologists 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.
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 intubations 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 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 EC approval of Bridion follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) was received in May of this year.