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Organon's Sugammadex Demonstrated a 9-12 Times Faster Recovery in,Phase III Pivotal Trial as Compared to Neostigmine

OSS, The Netherlands, June 11, 2007 /PRNewswire/ -- Sugammadex - the novel selective relaxant binding agent (SRBA) being developed by Organon, the human healthcare business unit of Akzo Nobel - demonstrated in a Phase III pivotal trial a 9-12 times faster reversal of neuromuscular blockade as compared to neostigmine, without evidence of post operative residual curarization (PORC) or re-occurrence of muscle relaxation.(1),(2) The results of this pivotal Aurora trial were presented today at the 14th annual Euroanaesthesia 2007 congress in Munich, Germany.

The Aurora trial compared the efficacy of sugammadex and neostigmine for the reversal of shallow neuromuscular blockade induced by single or multiple doses of either rocuronium (Esmeron(R)/Zemuron(R)) or vecuronium (Norcuron(R)).

"Sugammadex has shown a rapid and complete reversal in this pivotal trial without evidence of PORC or re-occurrence of neuromuscular blockade. Effective reversal is critically important to ensure that patients recover quickly and completely, without the risk of breathing difficulties," commented one of the lead investigators involved in the Aurora trial, Professor M. Blobner from the Klinik fur Anasthesiologie der Technischen Universitat Munchen, Germany.

Reversal agents are used during general anesthesia to reverse the effects of muscle relaxants, also called neuromuscular blocking agents (NMBAs). Reversal of neuromuscular blockade is used to reduce the risk of PORC or re-occurrence of muscle relaxation.

Phase III Trial Overview

The international, randomised, multicenter, parallel-group Aurora trial was conducted at 13 European centers and enrolled 198 patients. In the trial sugammadex was administered at reappearance of T2 and achieved significantly faster recovery of the T4/T1 ratio to 0.9 compared with neostigmine. Median time to recovery was 1.4 minutes (0.9-5.4; p<0.0001) for sugammadex versus 17
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