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Orexo's sublingual sleep drug outperforms Ambien

Orexo reveals positive results in a comparative phase III profile study of its Sublinox sleep aid at the Associated Professional Sleep Societies conference

Swedish-headquartered pharmaceutical and drug delivery company, Orexo, has presented positive results in completed comparative phase III profile study of its Sublinox (OX22) sleep aid at the Associated Professional Sleep Societies (APSS) conference in Salt Lake City in the US.

Orexo has completed a pharmacological profile study for Sublinox for the treatment of temporary sleeping disturbances. The study showed that the treatment acts 30 per cent faster than sanofi-aventis' Ambien (zolpidem) as a treatment for patients suffering from sleep disturbances.

The study also showed that patients stayed asleep during the night, supporting existing evidence that Sublinox is 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 the company will submit to the FDA later in 2007.

Sublinox, which also contains zolpidem, is based on Orexo's sublingual technology, which combines fast oral disintegration 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 muco-adhesive units of the active substance.

According to Datamonitor, the launch of serotonin antagonists aimed at treating sleep maintenance could add substantial value to the insomnia market, increasing from USD 6.1bn in FY06 to USD 7.7bn in 2016.

Serotonin receptor antagonists are the most prevalent drug class in the late-stage insomnia pipeline and represent a departure from GABA agonists which currently dominate the market.

Datamonitor adds that serotonin antagonist companies will be important players in the market in the future, led by sanofi-aventis' eplivanserin. The majority of pipeline drugs are being investigated for sleep maintenance as opposed to sleep onset insomnia and there is a trend toward the development of drugs for the treatment of co-morbid disorders.

In March 2007, Merck & Co and Lundbeck discontinued development of their phase III drug, gaboxadol, over disappointing trial results.

Zsolt Lavotha, President and CEO of Orexo, said: ìThe recently completed profile study confirms that Sublinox is a fast-acting sleep aid that allows patients to sleep throughout the night without increased 'day-after' residual effects. We will be intensifying ongoing discussions with licensing partners.î

30th September 2008

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