Insomnia Compound (Org 50081) Shows Promise As It Moves Into Phase Iii Clinical Trials

Main Category: Clinical Trials / Drug Trials
Also Included In: Sleep / Sleep Disorders / Insomnia
Article Date: 02 Jan 2007 - 9:00 PDT

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Organon, the human healthcare business unit of Akzo Nobel, has moved Org 50081, a Serotonin 2 blocker (S2B) for the treatment of insomnia, into Phase III clinical development. About 70 million Americans each year suffer from symptoms of insomnia, which can lead to problems with daytime functioning. Insomnia tends to occur more often in elderly and women and is associated with an increased risk for developing other illnesses such as depression. The number of people treated for insomnia is expected to substantially increase over the next several years.

Willem de Laat, executive vice-president medical affairs at Organon said “Investigated dosages of the Org 50081 compound showed positive and robust results on multiple sleep parameters such as total sleep time and wakefulness after sleep onset. A statistically significant shorter time to sleep onset was demonstrated in Org 50081 treatment groups compared to placebo.”

The Serotonin-2 blockade of Org 50081, is unique for an insomnia drug. Unlike most other insomnia drugs, which work by interacting with the GABA receptors and thus have a potential risk for dependency, Org 50081’s action is on the serotonergic and histaminergic systems. As such, while Org 50081 may improve both sleep initiation and sleep maintenance it is not likely to cause dependency.

“Patients who suffer from insomnia need to have a treatment without addictive properties. A treatment such as Org 50081 could help the patients tremendously if it proves successful in Phase III.” said Toon Wilderbeek, the Akzo Nobel board member responsible for Pharma, who is also president of Organon.

Org 50081 is currently in Phase III development for two major indications: insomnia and menopausal symptoms (hot flashes).

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About Organon
Organon - with shared head offices in Roseland, NJ, USA and Oss, The Netherlands - creates, manufactures and markets innovative 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 biopharmaceutical companies in each of its core therapeutic fields: fertility, gynecology, anesthesia and neuroscience. Research areas also include immunology and oncology.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.

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Organon BioSciences
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