SAN FRANCISCO, Oct. 16 /PRNewswire/ -- Sugammadex -- the novel selective relaxant binding agent (SRBA) being developed by Organon -- demonstrated a faster recovery from profound neuromuscular blockade as compared to neostigmine in the Phase III pivotal Signal trial.(1) In a second trial, named Spectrum, faster recovery from profound neuromuscular blockade compared to spontaneous recovery was demonstrated.(2) The pivotal Signal trial results were presented today at the 2007 annual meeting of the American Society of Anesthesiologists (ASA) taking place in San Francisco from October 13-17. The Spectrum trial results were presented on October 14.
The Signal trial compared the efficacy and safety of sugammadex and neostigmine/glycopyrrolate for the reversal of profound rocuronium (Zemuron(R)/ Esmeron(R)/Eslax(R)) induced neuromuscular blockade. The Spectrum trial compared the efficacy and safety of sugammadex for reversal of profound rocuronium-induced neuromuscular blockade with that of spontaneous recovery from succinylcholine-induced blockade.
"The Signal trial results are clinically significant for anesthesiologists during neuromuscular blockade management, as with sugammadex they will be able to have control when using any depth of rocuronium-induced neuromuscular, and be able to reverse the blockade rapidly at any moment they want, which is not possible with current treatments," said Professor James E. Caldwell, University of California, San Francisco and one of the lead Signal trial investigators.
Reversal agents are used during general anesthesia to reverse the effects of muscle relaxants, also called neuromuscular blocking agents (NMBAs). Reversal of neuromuscular blockade enables spontaneous breathing to recommence earlier which helps to get patients out of the operating room quicker, freeing up capacity and personnel to help additional patients. Adequate reversal reduces the risk of residual paralysis, which may cause a number of serious complications such as muscle weakness and breathing difficulties. NMBAs are often administered during surgery to enable endotracheal intubation and provide total skeletal muscle relaxation when the surgery requires that patients' muscles are relaxed during the procedure.
Professor Caldwell added, "Also, the results of the Spectrum trial are important because it indicates that the combination of rocuronium followed by sugammadex can provide faster recovery from neuromuscular blockade than spontaneous recovery from succinylcholine, the shortest acting NMBA currently available."
About the Signal trial(1)
This profound block trial was a multicenter, parallel-group study among adult patients undergoing surgery in the supine position (patient on his/her back). Rocuronium (0.6 mg/kg) was administered for intubation, followed by maintenance doses (0.15 mg/kg) as required. When reversal was needed, patients were randomized to receive either sugammadex (4.0 mg/kg) or neostigmine (70 micrograms/kg) plus glycopyrrolate (14 micrograms/kg).
In the intent-to-treat population (37 patients in each group), the mean time to recovery of the T(4)/T(1) ratio to 0.9 with sugammadex was 2.9 minutes, compared to 50.4 minutes with neostigmine/glycopyrrolate (p< 0.0001), a confirmed 17 times faster reversal with sugammadex.
The most frequently reported adverse events (AEs) for the sugammadex and neostigmine groups regardless of relationship to the study drug were procedural pain (70 vs. 76%) and nausea (38 vs. 50%). For both groups no serious drug-related adverse events were reported. Clinical chemistry results were similar between groups. No patients had clinical evidence of recurarization or residual curarization.
About the Spectrum trial(2)
In this second profound block trial, 110 patients undergoing elective surgery requiring short duration of neuromuscular relaxation were randomized to receive either an intubating dose of rocuronium 1.2 mg/kg 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.
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 Phase III trials were presented.
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.
Safe Harbor Statement*
This press release may contain statements which address such key issues as growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals of Organon. Such statements should be carefully considered, and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, progress of drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated comparative positions are based on management estimates supported by information provided by specialized external agencies. For a more comprehensive discussion of the risk factors affecting our business please see our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the company's corporate website www.akzonobel.com.
* Pursuant to the U.S. Private Securities Litigation Reform Act of 1995.
CONTACT: Global Media: Monique Mols, Director Media Relations of Organon,
+31-(0)412-665440, email@example.com, or US Media: Fran DeSena,
Senior Director, Communications & Media Relations of Organon USA,
Web site: http://www.akzonobel.com/