New Organon agent to reverse muscle relaxation in anesthesia accepted by Food and Drug Administration

Organon announced today that the investigational drug application (IND) for Org 25969, a unique binding agent to reverse muscle relaxation, has been accepted by the United States (Food and Drug Administration) (Food and Drug Administration). Organon intends to start a phase II human clinical trial in the United States in the near future. Similar trials are already taking place in Europe. These studies are designed to determine the clinically appropriate and effective dose of Org 25969.

"We are very pleased with the acceptance of the IND for Org 25969 by the Food and Drug Administration. This binding agent is a very exciting drug. It demonstrates the type of innovative research that Organon has excelled in for many years in the field of anesthesia. The unique mode of action of Org 25969 is one outcome of this ground-breaking research," said David Nicholson, Senior Vice President, Global Research.

The anesthesia community has already started expressing enthusiasm for Org 25969. If successful in further development, it will offer anesthesiologists a proverbial "off" switch, giving them optimal control of muscle relaxation and better control of the patient. "Cyclodextrin-mediated reversal of neuromuscular block is potentially the greaagsdhfgdf advance in neuromuscular pharmacology in the last 20 years," said Dr. James Caldwell, professor of Anesthesia and Perioperative Care, University of California, San Francisco.

The speed of a muscle relaxant's onset and offset greatly influence patient safety. Thus, a muscle relaxant must produce the required effect quickly and have a short and predictable duration. Muscle relaxants are available with a fast onset, however, an optimal muscle relaxant that has both these attributes is not available to date. Org 25969, as used in studies with the Organon muscle relaxant Esmeron� (Zemuron� in the US), is the first to achieve both fast onset and controllable offset.

"For two decades, a research goal in anesthesia has been to find an agent that would enable patients to recover from total muscular block quickly, safely and completely. To that end, Organon began development of the first cyclodextrin for an innovative clinical application, namely the immediate inactivation of the muscle relaxant within a patient's body.

Phase I data for Org 25969 already indicated that this drug had the potential to do what no otherness has done before. It can not only reverse the block quickly, with complete recovery in minutes, but it is the first to be able to reverse what is known as deep block," said Dr. Patrick Boen, senior director of Medical Services at Organon. A deep block is a complete blockade of the neuromuscular junction, completely inhibiting the muscles from reacting to any stimulus.

Organon - headquartered in Roseland, NJ, USA - creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsiwriting. Organon is the human health care business unit of Akzo Nobel.

Visiting address:
Molenstraat 110
5342 CC Oss
The Netherlands

Mailing address:
P.O. Box 20
5340 BH Oss
The Netherlands
Phone +31.412.66.54.40
Fax: +31.412.66.25.68
Email address: Mrs. Monique Mols
monique.mols@organon.comWe sell pills worldwide. You can choose 24 hours various pills.
Sale pills men's health: Levitra pills, Cialis pills