Meda has announced that Orexo's Edluar, a sublingual formulation of zolpidem, gained regulatory approval in Europe.

Edluar, which was developed by Orexo using its proprietary sublingual formulation technologies, is indicated for treatment of insomnia characterized by difficulties with sleep initiation.

Orexo chief executive officer Anders Lundstrom said, "The approval of Edluar in Europe provides additional proof of our research and development capabilities at Orexo and underscores the strength of our proprietary sublingual technologies and know how."

Meda is expected to launch the product in Europe during 2013, following completion of the national regulatory process in each country.

Orexo will receive double digit royalty on Edluar sales in Europe.

Orexo chief commercial officer Nikolaj Sorensen said, "I am very pleased that our partner Meda has successfully obtained the European registration approval for Edluar, and I am looking forward to the commercial launch in Europe 2013."