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Sugammadex Trials Demonstrate Rapid Recovery from Profound Neuromuscular Blockade During General Anesthesia
Date:10/16/2007

followed by sugammadex 16 mg/kg, 3 minutes after the start of rocuronium administration or received an intubating dose of the short acting muscle relaxant succinylcholine of 1.0 mg/kg to be followed by spontaneous recovery.

From the start of neuromuscular blocking agent administration, mean (SD) time to recovery of T(1) to 90% was faster in the rocuronium/sugammadex group [6.2 (1.8) vs. 10.9 (2.4) minutes with succinylcholine, p< 0.0001]. In the rocuronium/sugammadex group, time to recovery of T(1) to 90% from the start of sugammadex administration was 2.9 (1.7) minutes.

The most frequently reported adverse events (AEs) for the rocuronium/sugammadex and succinylcholine groups regardless of relationship to the study drug were procedural pain (57 vs. 48%) and nausea (29 vs. 37%). For both groups no serious drug-related adverse events were reported. No patients had clinical evidence of recurarization or residual curarization.

References

(1) Jones K et al. Faster Reversal of Profound Rocuronium-Induced

Neuromuscular Blockade with Sugammadex vs. Neostigmine.

Anesthesiology 2007; 107: A1577.

(2) Lee C et al. Reversal of Profound Rocuronium NMB with Sugammadex Is

Faster Than Recovery from Succinylcholine. Anesthesiology; 107: A988.

About sugammadex

In the clinical trials conducted to date as part of the Phase III Bright program, sugammadex has demonstrated the ability to reverse shallow and profound depths of rocuronium-induced neuromuscular blockade, thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs. Sugammadex's global Phase III development program -- consisting of 5 U.S. trials and 5 European trials -- has been completed. The acceptance for review by the EMEA was announced on July 20, 2007. The anticipated submissions for the U.S. and Japan are on schedule for later this year. During this ASA annual meeting results from four additional Pha
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SOURCE Organon
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