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news.Meda has announced that the submitted registration application for Sublinox has been accepted by the FDA as complete for substantive review after initial evaluation.
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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.”