( owing rocuroniumadministration; and 2....)Organon's Sugammadex Demonstrated a 9-12 Times Faster Recovery in,Phase III Pivotal Trial Compared to Neostigmine,Health

owing rocuronium administration; and 2.1 minutes (1.2-64.2; p<0.0001) versus 18.9 minutes (2.9-76.2); p<0.0001) respectively following vecuronium administration. There were no clinical events due to PORC or re-curarization reported for either group.1, 2 In total 34 patients from this trial experienced one or more adverse events (AE) that were considered at least possibly related to the study drugs: 14 in the sugammadex group and 20 in the neostigmine group. Most drug-related AEs were mild or moderate. The most commonly reported AEs (>4%) with sugammadex included dry mouth, nausea, vomiting, chills and procedural hypertension. Neostigmine was most commonly associated (>4%) with prolonged neuromuscular blockade, dry mouth, nausea, procedural complication and albumin present in urine.[1, 2] During the congress, results from three additional Phase III trials – Libra, Spring and Crystal trials - were presented. These trials demonstrated that sugammadex was effective and well tolerated in pediatric patients, in patients with mild or moderate impaired renal function and in comparison with neostigmine-glycopyrrolate after cisatracurium. Most common AEs (>4%) considered at least possibly related to sugammadex in these studies were diarrhoea, anesthetic complication and increased D-glucosaminidase.[3, 4, 5] In the clinical trials conducted to date, sugammadex has generally demonstrated the ability to reverse shallow and profound depths of rocuronium-induced neuromuscular blockade within 3 minutes, thereby enabling unprecedented 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 US trials and 5 European trials - completed recruitment in late 2006. The submission of the registration files for the USA, Europe and Japan are on schedule. About Organon
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