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Schering-Plough announces new drug application for sugammadex assigned priority review status by U.S. FDA[Изображения доступны только зарегистрированным пользователям][Изображения доступны только зарегистрированным пользователям][Изображения доступны только зарегистрированным пользователям][Изображения доступны только зарегистрированным пользователям]

Wednesday, January 02, 2008 (Kenilworth, USA)
Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the company’s New Drug Application (NDA) for sugammadex.

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Sugammadex is specifically designed to reverse the effects of certain muscle relaxants, marketed in the United States as ZEMURON® (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. If approved, sugammadex will be the first in a new class of drugs known as selective relaxant binding agents that work in an entirely new and unique way to encapsulate the muscle relaxant molecule and render it inactive.
“Organon, now part of Schering-Plough Corporation, has had a strong presence in the anesthesia market for over 35 years,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “The development of sugammadex is an exciting advance for the practice of anesthesia. This novel drug has the potential to change the way doctors practice anesthesia as it will allow anesthesiologists to rapidly and safely reverse both shallow and profound levels of muscle relaxation, which is not possible with current reversal agents.”
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®/ESLAX®) 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 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.
About ZEMURON
ZEMURON (rocuronium bromide) is a non-depolarizing muscle relaxant. It was introduced in the United States in 1994 and is one of the most widely used muscle relaxants in the United States, Canada and many European countries (where it is marketed under the brand name ESMERON). It was approved for use in Japan on July 31, 2007, under the brand name ESLAX. To date, it has been used in over 140 million patients worldwide, including an estimated 20 million patients in 2006.
Important Safety Information
There have been rare reports of severe anaphylactic reactions to ZEMURON (rocuronium bromide) Injection, including some that have been life threatening. Clinicians should be prepared for the possibility of these reactions and take the necessary precautions, including the immediate availability of emergency treatment. ZEMURON Injection should be administered by experienced clinicians who are familiar with the drug’s actions and the possible complications of its use. For Full Prescribing Information please go to [Ссылки доступны только зарегистрированным пользователям ] or [Ссылки доступны только зарегистрированным пользователям ].