The data supporting the product includes a clinical study in insomnia patients that was completed in October 2007. That study showed that Sublinox induced sleep 30% earlier compared to Ambien and that patients remained asleep throughout the night with comparable safety.
Sublinox contains the active substance zolpidem and is based on Orexo’s sublingual technology, involving a rapidly disintegrating tablet placed under the tongue.
Meda acquired the exclusive world-wide commercialization rights for Sublinox on April 14, 2008.
Anders Lonner, CEO of Meda, said: “This FDA’s acceptance increases the chances for a registration approval during 2009.”