Novel Organon Agent to Reverse Muscle Relaxation in Anesthesia - FDA Agreement on Phase 3 Development Plan

Main Category: Neurology / Neuroscience
Article Date: 18 May 2005 - 16:00 PDT

email to a friend   printer friendly   opinions  

Organon and the US Food and Drug Administration (FDA) have reached agreement on the clinical development plan that will allow Org 25969 - the first selective relaxant binding agent to reverse neuromuscular block - to enter Phase 3 studies. The decision follows an End of Phase 2 meeting earlier this month, during which the FDA accepted the plans with only minor requests for additional data.

"We are very pleased that the FDA has agreed with our plans for Phase 3 development. There is no doubt that Org 25969 - if successful in further development - will be one of the most significant advances in neuromuscular pharmacology in the last 20 years. Indications to date are positive" commented Dr Willem de Laat, Executive Vice President, Development and Medical Affairs from Organon.

Reversal agents are administered after surgical procedures involving the use of muscle relaxants (neuromuscular blocking agents or NMBAs) to enable spontaneous breathing to recommence earlier. Current reversal agents can only be administered when muscle relaxation is starting to wear off naturally, delaying the possibility of reversing the blockage up to 30 minutes. They also have various side effects including cardiovascular effects.

Org 25969 - a selective relaxant binding agent (SRBA) - can achieve reversal following Esmeron® (rocuronium bromide; one of the most widely used NMBAs) administration within three minutes regardless of the depth of block and to date has shown less adverse effects than the currently available agents. (Org 25969 is a modified cyclodextrin compound, which by itself does not have an appreciable activity in the body.)

The Phase 3 trials are expected to start in June and will involve approximately 1500 patients. They will assess reversal following administration of rocuronium and vecuronium. Results are expected in 2006 indicating that Org 25969 could be available as early as 2007.

Full data from three Phase 2 studies will be presented at the European Society of Anaesthesia Congress in Vienna, Austria later this month.

Organon - with shared head offices in Roseland, New Jersey, U.S.A. and Oss, The Netherlands - creates, manufactures 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 remain or become 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 subsidiary. Organon is the human health care business unit of Akzo Nobel. Additional information about Organon is available through its corporate website, http://www.organon.com.

For more information, please contact:
Monique Mols, Associate Director, Media Relations
Tel: +31-(0)412-665440, e-mail: monique.mols@organon.com

• Additional
• References
• Citations