LEVITRA 10mg Orodispersible Tablet for the Treatment of Erectile Dysfunction approved in Europe

The Bayer GroupThe European Commission has approved a new formulation of Levitra® (vardenafil HCI). Levitra 10mg orodispersible tablet will be the first erectile dysfunction (ED) medication available in this novel and convenient formulation. In contrast to other drugs of the same class, Levitra 10mg orodispersible tablet allows men a discreet and convenient intake without water, dissolving on the tongue within seconds with a minty flavour. In Europe the launch roll-out will start as of November 2010. In the United States the medication has been approved in June 2010 and will be marketed by GlaxoSmithKline and Merck & Co., Inc. under the tradename STAXYN™.

"Bayer Schering Pharma is committed to men's health and continuously striving to find new and innovative treatment options in the treatment of erectile dysfunction," said Dr. Flemming Oernskov, Head of the Business Unit Women's Healthcare and General Medicine at Bayer Schering Pharma in Berlin. "As part of these efforts, we believe men with ED will appreciate a convenient and easy to take medication. Levitra orodispersible tablet allows men with ED to be prepared, anytime, anywhere. This should help to bring spontaneity into the sex life of men with ED."

The overall efficacy and safety of vardenafil has been widely demonstrated in numerous clinical trials (1–10). For this registration, Levitra 10mg orodispersible tablet was tested in the Phase III multinational trials POTENT I and II (Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction: a fixed-dose, double-blind, raNdomized multicenter Trial). These pivotal studies compared the efficacy and safety of 10mg vardenafil orodispersible tablet with placebo after 12 weeks of treatment in a general population of men with ED. These two international twin studies were conducted with identical study design, enrolling a total of 882 men above the age of 18 years who had ED for more than 6 months. (11,12), For both POTENT I and POTENT II studies, vardenafil orodispersible therapy was statistically significantly superior to placebo for all primary (IIEF-EF, SEP2, SEP3) and secondary efficacy measures (all p<0.0001).

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 (13), experience erection difficulties. It is predicted that the worldwide prevalence of ED will increase to 322 million by 2025 (14). Despite its wide prevalence, recent data suggest that many men with ED do not seek treatment. Moreover, ED can be a first signal for cardiovascular comorbitidies and should therefore be taken seriously by patients and physicians (15). 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.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover, manufacture and markets products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.

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