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Schering-Plough suggests sugammadex could “transform the practice of anaesthesia”
Schering-Plough has suggested that sugammadex could “transform the practice of anaesthesia” through the improved management of muscle relaxation.
Robert J Spiegel, chief medical officer and senior vice-president of the Schering-Plough Research Institute, indicated that sugammadex would provide a boost to the “millions of surgeries” that were using selective relaxant binding agents.
His comments arrive after the US Food and Drug Administration Advisory Committee on Anaesthetics and Life Support recommended sugammadex for approval.
After reviewing safety and efficacy data for the medication, the committee unanimously recommended approval of Schering-Plough’s application for marketing.
The FDA is not bound by the recommendations but considers them carefully before making a recommendation.
Welcoming the committee decision, Mr Spiegel said: “We are very pleased with the outcome of today’s advisory committee meeting and appreciate the panel’s careful consideration of the data on sugammadex.”
Sugammadex is designed to reverse the effects of rocuronium and vecuronium muscle relaxants used as part of general anaesthesia during surgical procedures.
It encapsulates the muscle relaxant molecule and restores muscle function so that patients can breathe independently.
Earlier this year, Schering-Plough announced that sugammadex had been filed for approval in Japan.
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