Orexo Shows Positive Results In Completed Comparative Phase III Profile Study Of The Sublinox Sleep Aid Involving Insomnia Patients

Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 02 Oct 2007 - 3:00 PDT

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Orexo has completed a pharmocological profile study for Sublinox™ (OX22) - for treatment of temporary sleeping disturbances. The study shows that Sublinox™ (OX22) acts 30 percent faster than Ambien® as a sleep aid for patients suffering from sleep disturbances. The study also shows that patients remain asleep throughout the night and strengthens existing documentation that Sublinox™ (OX22) represents a safe and effective treatment for temporary insomnia.

The completed effects study, combined with additional clinical documentation produced by Orexo, will serve as the basis for the registration application that Orexo plans to submit to the FDA later this year.

"The recently completed profile study confirms what we presented at the APSS (Associated Professional Sleep Societies) conference in Salt Lake City, Utah in the US - that Sublinox™ (OX22) is a fast-acting sleep aid that allows patients to sleep throughout the night without increased "day-after" residual effects," says Zsolt Lavotha, President and CEO of Orexo AB. "The results of the study show that our product shortens sleep induction by more than 30 percent compared with Ambien®, which in combination with the expected safety profile, represents a significant competitive advantage over existing sleep products. We will be intensifying ongoing discussions with licensing partners."

Sublinox™ (OX22), which contains the well-documented substance zolpidem, is based on Orexo's sublingual technology, involving a tablet placed under the tongue for fast and effective absorption of the active substance across the oral mucosa.

About Orexo

Orexo is a pharmaceutical company which focuses on identifying suboptimal therapeutic characteristics of existing products and developing more efficient and effective delivery methods for them. By combining approved active substances with Orexo´s drug delivery technologies it is possible to significantly enhance their therapeutic value, such as providing quicker onset of action or ease of administration. This business model is aimed at bringing products to market faster with lower development risk and costs.

Orexo, which has its global headquarters and development laboratories in Sweden, currently operates across the world through development, licensing and distribution agreements in all major markets.

Orexo has a balanced portfolio with two products on the market, three in registration and/or late stage clinical phase, one in clinical phase I and one under formulation development.

Orexo is listed on the OMX Nordic List Mid Cap (ticker;ORX). http://www.orexo.com

About insomnia

Sleep is vital. It´s during sleep the body recovers and the brain works with and stores information. Most part of all learning takes place during sleep. Besides, the stress hormone cortisol is reduced during sleep.

Lack of sleep leads to stress, which in turn leads to poorer sleep and can lead to anxiety, less pain resistance and as an extension, to depression. At loss of sleep the ability to among others, perform activities of daily life demanding attention, thinking or make decisions, are influenced. Other effects of lack of sleep are, for example, shifts of temper, difficulties with coordination and ache.

About Orexo´s oral sublingual tablet formulation

Orexo´s sublingual tablet technology combines fast disintegration and dissolution in the oral cavity with rapid, site-specific absorption of the active substance across the sublingual mucosa.

When administered, the tablet is placed under the tongue where it rapidly disintegrates into ordered mucoadhesive units of the active substance. Orexo believes that the rapid and reproducible absorption of the active substance makes the dosage form ideal for treatment of conditions requiring immediate onset of effect.

http://www.orexo.com