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.