Sublinox (Edluar) approved in Canada

Uppsala, Sweden, July 25 2011 – The insomnia drug Sublinox (Edluar) has been approved in Canada. Meda and its partner Valeant expect to begin the launch in the fourth quarter 2011.

Sublinox will be marketed by the joint venture between Meda and Valeant, Meda Valeant Pharma Canada Inc. Meda has global rights to the drug and markets it in the USA since 2009 under the name Edluar. Orexo, who has developed the drug, is entitled to royalties on sales.

The approval is for short-term treatment of insomnia. Sublinox is based on Orexo's sublingual tablet technology. The drug is placed under the tongue where it rapidly disintegrates and the active substance zolpidem is absorbed through the oral mucosa.

For further information, please contact:

Anders Lundström, President and CEO, Orexo AB

Tel: +46 706 67 22 66


About Sublinox/Edluar

Sublinox (Edluar in the USA) is based on Orexo’s sublingual tablet technology and the active substance zolpidem and offers treatment for short-term insomnia. The tablet is placed under the tongue where it rapidly dissolves and the active substance is absorbed through the mucous membrane. The drug is approved in the USA for the treatment of short-term insomnia.

About Orexo

Orexo is a pharmaceutical company focusing on developing treatments for pain and inflammation. The company has four commercialized products, several projects developed in partnership as well as three proprietary development programs. Orexo’s registered products are Abstral® for the treatment of break through cancer pain, sold by Kyowa Hakko Kirin/ProStrakan Group plc. in Europe and in the USA, the sleeping pill Edluar™, sold by Meda in the USA, as well as two products for the diagnosis of Helicobacter pylori which are being marketed by the subsidiary Kibion. More information can be found at

Orexo AB (publ) discloses the information provided in this press release pursuant to the Securities Markets Act. The information was provided for public release on 25 July 2011 at 08:00 CET. This press release has been prepared in both Swedish and English. In the event of any discrepancy in the content of the two versions, the Swedish version shall take precedence.