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Vardenafil Orodispersible Tablet

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Abstract

Vardenafil orodispersible tablet (ODT) is a supralingual formulation of vardenafil that is available for the on-demand treatment of erectile dysfunction.

The pharmacokinetics of vardenafil ODT are not equivalent to those of the vardenafil film-coated tablet in that the ODT formulation provides consistently greater vardenafil systemic exposure. Therefore, the two formulations are not interchangeable.

The efficacy of on-demand vardenafil ODT 10 mg was established in the POTENT I and II studies, which were 6-week, randomized, double-blind, multinational trials in men with erectile dysfunction of at least 6 months duration. In both trials, vardenafil ODT improved erectile function significantly more than placebo, as indicated by International Index of Erectile Function-Erectile Function subscale scores at week 12 and overall erection success rates during treatment according to responses to questions 2 and 3 of the Sexual Encounter Profile (coprimary endpoints).

In a pooled analysis of both trials, vardenafil ODT improved erectile function regardless of age, severity of erectile dysfunction at baseline or the presence or absence of underlying medical conditions.

Vardenafil ODT was generally well tolerated in clinical trials, including in men aged ≥65 years, and adverse events were mostly mild or moderate in severity.

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Acknowledgements and Disclosures

The manuscript was reviewed by: R.K. Campbell, College of Pharmacy, Washington State University, Pullman (WA), USA; C. De Creé, Department of Medicine and Surgery, University of Rome, Rome, Italy; I.H. Derweesh, Division of Urology, Department of Surgery, University of California San Diego School of Medicine, La Jolla (CA), USA; S. Ferrero, Department of Obstetrics and Gynaecology, San Martino Hospital and University of Genoa, Genoa, Italy.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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Correspondence to Mark Sanford.

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Sanford, M. Vardenafil Orodispersible Tablet. Drugs 72, 87–98 (2012). https://doi.org/10.2165/11208270-000000000-00000

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