Schering-Plough has been celebrating the news that European regulators have given the green light to sugammadex, which reverses the effects of anaesthesia after surgery.

The European Commission has approved sugammadex, an injection which will be marketed as Bridion, for the reversal of neuromuscular block induced by rocuronium or vecuronium. The latter are given as part of general anaesthesia to relax a patient's muscles during surgery.

S-P says that Bridion is the only selective relaxant binding agent and the first major pharmaceutical advance in the field of anesthesia in two decades. It works by encapsulating the muscle relaxant molecule, rendering it inactive, and was specifically designed to reverse “within minutes both moderate and deep muscle relaxation” induced by rocuronium or vecuronium. This may help improve surgical conditions “in the millions of procedures where these agents are used”, the firm added, noting that the approval is based on a clinical trial database of approximately 1,800 patients.

Thomas Koestler, president of Schering-Plough Research Institute, noted that this is the first major approval of a product to come out of its 11 billion-euro acquisition of Organon BioSciences from the Dutch firm Akzo Nobel, completed last November. This further validates the value of our combination, which…is already making a positive contribution to our business", he added.

S-P is still waiting for final approval from the US Food and Drug Administration for Bridion, which was recommended by a panel of advisers to the agency in March. Analysts have forecast that sales of sugammadex could top $500 million worldwide by 2012.