US FDA assigns priority review status to Schering-Plough's NDA for sugammadex

Schering-Plough Corporation announced that the US Food and Drug Administration (FDA) has assigned priority review status to the company's New Drug Application (NDA) for sugammadex.

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 anaesthesia 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 anaesthesia market for over 35 years," said Robert J Spiegel, MD, chief medical officer and senior vice president, Schering-Plough Research Institute. "The development of sugammadex is an exciting advance for the practice of anaesthesia. This novel drug has the potential to change the way doctors practice anaesthesia as it will allow anaesthesiologists 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.

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. Anesthesiologists use muscle relaxation to improve surgical conditions, to facilitate intubation and mechanical ventilation, and to reduce the chance of complications.

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.