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11.06.2007 – 12:05

N.V. Organon

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

Oss, The Netherlands (ots/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
für Anästhesiologie der Technischen Universität München, 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 17.6 minutes (3.7-106.9;
p<0.0001) for neostigmine following 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.
Notes
(1) Blobner M, Eriksson L, Scholz J, Hillebrand H, Pompei L.
Sugammadex (2.0 mg/kg) significantly faster reverses shallow
rocuronium-induced neuromuscular blockade compared with neostigmine
(50 mcg/kg). Eur J Anaesthesiol. 2007;24(Suppl 39):125.
(2) Alvarez-Gomez JA, Wattwil M, Vanacker B, Lora-Tamayo JI,
Khünl-Brady KS. Reversal of vecuronium-induced shallow neuromuscular
blockade is significantly faster with sugammadex compared with
neostigmine. Eur J Anaesthesiol. 2007;24(Suppl 39):124-125.
(3) Staals LM, Snoek MMJ, Flockton E, Heeringa M, Driessen JJ. The
efficacy of sugammadex in subjects with impaired renal function. Eur
J  Anaesthesiol. 2007;24(Suppl 39):122-123.
(4) Plaud B, Meretoja O, Pohl B, Mirakhur RK, Raft J. Reversal of
rocuronium-induced neuromuscular blockade with sugammadex in
paediatric and adult patients. Eur J Anaesthesiol. 2007;24(Suppl
39):124.
(5) Flockton E, Scanni E, Gomar C, Shields M, Aguilera L.
Sugammadex  after rocuronium provides faster recovery from
neuromuscular blockade than neostigmine after cisatracurium. Eur J
Anaesthesiol. 2007;24(Suppl 39):123.
About Organon
Organon creates, manufactures and markets innovative prescription
Medicines that improve the health and quality of human life. Through
a  combination of innovation and business partnerships, Organon seeks
to  leverage its position as a leading biopharmaceutical company in
each of its  core therapeutic fields: fertility, gynecology and
selected areas of  anesthesia. It has extensive expertise in
neuroscience and a rich and focused R&D program. Research areas also
include immunology and specific areas of  oncology. Organon products
are distributed in over 100 countries worldwide,  of which more than
50 have an Organon subsidiary. Organon is the human  healthcare
business unit of Akzo Nobel.
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Annual Report on Form 20-F will be available in the second quarter of
2007.
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Contact:

For more information: Monique Mols, Director media relations, Tel:
+31-(0)412-665440, E-mail: monique.mols@organon.com