July 29, 2008 - The submitted registration application for SublinoxTM (OX22) has been accepted by the FDA as complete for substantive review after initial evaluation. SublinoxTM contains the well-known active substance zolpidem and is based on Orexo´s sublingual technology, involving a rapidly disintegrating tablet placed under the tongue.
Meda AB acquired the exclusive world-wide commercialization rights for SublinoxTM on April 14, 2008...
... The data supporting the product includes a clinical study in insomnia patients that was completed in October 2007... Orexo´s Press Release - [PDF] Meda AB's Press Release -
