A new orodispersible vardenafil formulation for the treatment of erectile dysfunction

Erectile dysfunction (ED) is a very common problem in men that is related to age and the presence of comorbidities. ED causes a considerable amount of stress and has a significant impact on his and his partner's quality of life. Despite the unquestionable advances made by the incorporation of iPDE-5 to the treatment of ED, an important challenge still lies ahead: the needs and preferences of the patient must be taken into account in a way that treatment can be adjusted as much as possible to these preferences, hence preserving and favouring the maintenance of spontaneity. Vardenafil, a highly selective iPDE-5 for the treatment of ED, has been shown to be safe and effective in a wide range of patients with different aetiologies and severity of ED, even in hard to treat patients who have had a radical prostatectomy and in diabetic patients. The new formulation of vardenafil orodispersible tablets ODT, marketed in one single 10 mg dose and taken as needed, does not need water to be administered and can be taken at any time anywhere, thus facilitating recovery of erectile function in a natural and spontaneous manner in those patients that need to resolve the problem convenient and privately. The pharmacokinetic profile of vardenafil ODT is very similar to that of the coated pills, with greater bioavailability. Results from efficacy studies are similar to those obtained with the 10 mg coated pill formulation in studies with a similar design and similar patient typology, with a significant superiority over placebo. Vardenafil ODT has been shown to be well-tolerated, with an incidence and type of treatment-related side effects that were compatible with the safety profile of the film-coated tablets. (C) 2011 Asociacion Espanola de Andrologia, Medicina Sexual y Reproductiva. Published by Elsevier Espana, S.L. All rights reserved.