Seeking marketing approval for its novel selective relaxant binding agent (SRBA), sugammadex, Nippon Organon K.K., now part of Schering-Plough Corporation, has filed a New Drug Application with the Japanese Ministry of Health, Labour and Welfare (MHLW).
Sugammadex is specifically designed to rapidly reverse the effects of certain muscle relaxants, rocuronium bromide (marketed in the US as Zemuron and in Japan as Eslax), as well as vecuronium bromide (marketed in Japan as Musculax). Muscle relaxants are used as part of general anaesthesia during surgical procedures.
On January 2, 2008, that the US Food and Drug Administration (FDA) has assigned priority review status to the New Drug Application (NDA) filing for sugammadex. Additionally, the Marketing Authorization Application for sugammadex was accepted for review by the European Medicines Agency (EMEA) in July 2007.
Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007.
Sugammadex is a novel selective relaxant binding agent (SRBA) under development by Organon, a part of Schering-Plough Corporation. Sugammadex was designed to reverse the effects of rocuronium bromide or vecuronium bromide, muscle relaxants commonly used during surgeries that require profound muscle relaxation. Anaesthesiologists use muscle relaxation to improve surgical conditions, to facilitate intubation and mechanical ventilation, and to reduce the chance of complications.
In clinical trials to date, sugammadex has demonstrated the ability to rapidly reverse shallow and profound depths of rocuronium-induced neuromuscular blockade (NMB), thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs. Sugammadex also has demonstrated the ability to reverse the effects of NMB induced by vecuronium bromide. In a phase III clinical trial, the most frequently reported adverse events associated with sugammadex regardless of relationship to the study drug were procedural pain and nausea.
Eslax (rocuronium bromide), marketed in the US as Zemuron, is a non- depolarising muscle relaxant. It was approved for use in Japan on July 31, 2007, under the brand name Eslax.