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FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
Date:3/11/2008

g-Plough announced that the FDA assigned priority review status to the company's New Drug Application (NDA) for sugammadex. In the U.S., priority review is granted to drugs that FDA believes will provide meaningful benefit over existing treatment options.

Sugammadex is specifically designed to reverse the effects of certain widely used muscle relaxants, marketed in the United States as ZEMURON(R) (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. Sugammadex works in an entirely novel way to encapsulate the muscle relaxant molecule and restore muscle function so that patients can breathe on their own again. Reversal with sugammadex is generally rapid and can even be used in emergency situations when immediate reversal of rocuronium is needed.

Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007.

About Sugammadex

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 (ZEMURON/ESMERON(R)/ESLAX(R)) or vecuronium bromide, muscle relaxants commonly used during surgeries that require profound muscle relaxation. Anesthesiologists 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 muscle relaxation, thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs(1). Sugammadex also has demonstrated the ability to reverse the effects of muscle relaxation induced by vecuronium bromide. The most common adverse reactions (incidence >5%) seen with sugammadex in clinical trials were anesthetic compli
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SOURCE Schering-Plough
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