Orexo has submitted the registration application (NDA) for Sublinox™ (OX22) to the FDA on May 14 2008

15 May 2008 · Pressrelease · Regulatory
Sublinox™ (OX22), for treatment of short term insomnia, contains the well-documented substance zolpidem, and is based on Orexo’s sublingual technology involving a tablet placed under the tongue.

This 505 (b) (2) NDA which is based on the clinical data completed October 2007. This data shows unique properties for Sublinox™ (OX22) in insomnia patients, including an earlier onset of sleep as compared to Ambien®. In addition to the earlier onset of sleep, the data also shows maintenance of sleep throughout the night. Sublinox™ (OX22) also offers a more convenient way of administration compared to oral tablets since it does not need to be swallowed with water. The first evaluation will take about two months and FDA will thereafter decide if the file is accepted for final evaluation.

Meda AB acquired the exclusive world-wide commercialization rights Sublinox™ (OX22) on April 14, 2008.

“This is an important first step to get Sublinox™ (OX22) out on the world market and we are proud of this accomplishment” said Torbjörn Bjerke, Orexo’s President and CEO.

For more information, please contact:
Torbjörn Bjerke, President and CEO, Orexo AB
Tel: +46 (0)708-66 19 90
E-mail: torbjorn.bjerke@orexo.com

Claes Wenthzel, Executive Vice President & CFO, Orexo AB
Tel: +46 (0)18-780 88 44
E-mail: claes.wenthzel@orexo.com