Schering Plough seeks approval for Sugammadex

A drug used to quickly reverse the effects of a range of muscle relaxants has been filed for approval in Japan by manufacturer Schering-Plough.

Sugammadex, a novel selective relaxing binding agent, is designed to invert the effects of rocuronium bromide and vecuronium bromide used in general anaesthesia procedures.

Clinical trials to date have shown the drug to “rapidly reverse shallow and profound depths” of neuromuscular blockade induced by rocuronium, while a phase III trial discovered side effects of nausea and procedural pain.

Schering-Plough announced its company Nippon Organon KK had filed an application for marketing approval with the Japanese ministry of health, labour and welfare, following a statement earlier in the month that the US Food and Drug Administration had given priority review status to Sugammadex.

The product was accepted for review in July of last year by the European Medicines Agency.

Meanwhile, earlier this week Schering-Plough unveiled its top-line results for the Ideal study, which compares leading therapies designed to treat chronic hepatitis C.