Orexo submits registration application (IND) to FDA to complete the Phase III clinical study for the insomnia product Sublinox™ (OX 22)

20 December 2006 · Pressrelease · Regulatory
Orexo AB has submitted a registration application to FDA to complete Orexo’s clinical Phase III program for the insomnia product Sublinox™ (OX 22) - Orexo´s patented product for treatment of temporary sleeping disturbances. The studies are expected to be completed in the second half of 2007. A registration application for the US and EU markets are estimated to be submitted at the end of 2007.

The global market for insomnia is valued at USD 3.7 billion. Orexo has in previous studies successfully proved that Sublinox™ (OX 22) shortens sleep induction in comparison with existing drugs and offers good and maintained sleep without ”day-after” residual effects.

”We now complete our clinical Phase III-program to further document Sublinox™ (OX 22) and its unique clinical profile in preparation for registration and out-licensing. This means that two of our products in short time have taken important steps towards registration and market entry”, says Zsolt Lavotha, President and CEO of Orexo AB.

Sublinox™ (OX 22) is a drug for the treatment of temporary sleeping disturbances. The product helps the patient to fall asleep quickly and remain asleep throughout the night. Sublinox™ (OX 22) is based on Orexo´s sublingual technology, involving a tablet placed under the tongue for fast onset of action and effective uptake of the active substance over the oral sublingual mucosa. The tablet contains the well documented substance zolpidem, one of the world´s most widely used substances for treating insomnia.

The technology is protected by patents in countries including the US, Japan and Australia.
A patent application has also been submitted to the European Patent Office. Discussions with potential partners for out-licensing of marketing rights for Sublinox™ (OX 22) are ongoing and are expected to be concluded during the first half of 2007.

For more information, please contact:
Zsolt Lavotha, President & CEO, Orexo AB
+46 (0)18 780 88 12, e-mail: zsolt.lavotha@orexo.se

Claes Wenthzel, Executive Vice President and CFO, Orexo AB
+46 (0)18 780 88 44, +46 (0)708-62 01 22, e-mail: claes.wenthzel@orexo.se