Orexo announced that the US Food and Drug Administration (FDA) has approved Edluar (formerly Sublinox) 5 mg and 10 mg sublingual tablets for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Orexo's partner Meda acquired the exclusive worldwide commercialization license for Edluar last year and they expect to launch the product in the US market during the 2nd half of 2009. Orexo will receive royalties on Meda's sales of Edluar.
This approval triggers a milestone payment to Orexo from Meda. The amount of the milestone is USD 5 million and is based upon the product labelling.
Commenting on the news Torbjörn Bjerke, CEO of Orexo, said, "I am delighted that the FDA has approved Edluar for the treatment of short-term insomnia. This is a great achievement by Orexo. Edluar provides a convenient sublingual administration and we believe that this offers insomnia sufferers an effective alternative. This is the second product approved in a major market within 12 months and is an excellent achievement. The milestone payment and the anticipated product launch during 2nd half of 2009 will continue Orexo´s progress towards profitability."
Edluar (formerly known as Sublinox) is a fast-acting, sublingual formulation of the well-known substance zolpidem and has been approved for the temporary treatment of insomnia.
Orexo is a pharmaceutical company focused on developing drugs for the treatment of pain and inflammation.