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BRIDION(R) (sugammadex) Injection - First and Only Selective Relaxant Binding Agent - Approved in European Union
Date:7/29/2008

oing surgery. Rocuronium was administered at a standard dose to allow intubation, followed by maintenance doses as required. When 1-2 post-tetanic counts (PTC) were observed following neuromuscular stimulation (deep block), patients were administered either sugammadex or neostigmine plus glycopyrrolate, a current reversal regimen. In the SIGNAL trial, the median time to reversal of muscle relaxation to a train-of-four (TOF) ratio of 0.9 occurred in 2.7 minutes in the sugammadex group compared to 49.0 minutes in the neostigmine/glycopyrrolate group.

The AURORA trial involved adult patients undergoing surgery. Rocuronium was administered at a standard dose to allow intubation, followed by maintenance doses as required. At the reappearance of the second twitch (T2) in a TOF stimulation (moderate block) patients were administered either sugammadex or neostigmine plus glycopyrrolate. In the AURORA trial, the median time to reversal of muscle relaxation to a TOF ratio of 0.9 occurred in 1.4 minutes in the sugammadex group compared to 17.6 minutes in the neostigmine/glycopyrrolate group.

The SPECTRUM trial was conducted in adult patients undergoing surgery to study the immediate reversal of muscle relaxation. Patients were randomized to receive either rocuronium plus sugammadex or the rapid-onset, short- duration muscle relaxant succinylcholine. The trial demonstrated that rocuronium followed by sugammadex is an effective alternative to succinylcholine.

The EC approval of BRIDION follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) that was received in May of this year.

About BRIDION (sugammadex)

BRIDION, the first and only selective relaxant binding agent (SRBA), is the first major pharmaceutical advance in the field of anesthesia in two decades. It was specifically designed to rapidly reverse both moderate and deep muscle relaxation induced by the commonly used m
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SOURCE Schering-Plough Corporation
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