New Levitra® formulation submitted for registration in the EU
First orodispersible tablet for the treatment of erectile dysfunction
Berlin. – Bayer Schering Pharma AG has submitted an application for registration of a new formulation of Levitra® (vardenafil HCI) in the European Union (EU). This new formulation is an orodispersible tablet containing 10mg vardenafil. In contrast to other drugs of the same class used for the treatment of erectile dysfunction, Levitra orodispersible tablet allows men a discreet and convenient intake without water, dissolving on the tongue within seconds.
“Erectile dysfunction is a troublesome condition that may heavily impact men’s well-being and their relationship”, said Jean-Philippe Milon, Ph.D., Head of Bayer Schering Pharma’s business unit General Medicine. “With the submission of this new formulation of Levitra, we have reached another important strategic milestone in the development of innovative and easy-to-use men’s health products.”
The efficacy and safety of Levitra 10mg orodispersible tablet have been demonstrated in two large clinical Phase III studies. The new formulation has shown in all studies the same efficacy and safety as the currently available tablet.
About Erectile Dysfunction
Erectile dysfunction (ED) is the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. An estimated 152 million men worldwide, 16 percent of all men aged 20-75 worldwide, experience erection difficulties. It is predicted that the worldwide prevalence of ED will increase to 322 million by 2025. Despite its wide prevalence, recent data suggest that many men, who are suffering from ED often do not seek treatment. Moreover ED can be a first signal for cardiovascular comorbitidies and should therefore be taken seriously by patients and physicians. More education and information on the physicians and patient side is needed to change this. Find more information about ED at www.in-bed.info.
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