Orexo shows positive results in completed comparative Phase III profile study of the Sublinox™ sleep aid involving insomnia patients

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.

For further information, please contact:

Zsolt Lavotha, President and CEO
Tel.: +46-18 780 88 12
E-mail: zsolt.lavotha@orexo.com

Claes Wenthzel, Executive Vice President and CFO
Tel: +46-18 780 88 44
E-mail: claes.wenthzel@orexo.com