Safety, Efficacy, and Patient and Partner Acceptability of Vardenafil Orally Disintegrating Tablets for the Treatment of Erectile Dysfunction

Staxyn (Bayer HealthCare Pharmaceuticals) is an oro-dispersible form of vardenafil. Oro-dispersible vardenafil functions in the same manner as other phosphodiesterase type 5 inhibitors to prevent the breakdown of cyclic guanosine monophosphate (cGMP), promoting greater erectile response and duration. Pharmacodynamic studies reveal a similar profile to vardenafil 10 mg, with greater bioavailability seen in the oro-dispersible form. Time to maximal concentration is slightly longer with orally dissolving vardenafil, although absorption through the oral mucosa decreases first pass metabolism. Few clinical studies exist on this formulation of vardenafil; however, those available reveal a similar effectiveness to film-coated vardenafil. The POTENT I and POTENT II trials are reviewed and provide the basis for most clinical data on this form of vardenafil. Staxyn has a safety profile comparable to other phosphodiesterase inhibitors, and a similar medication compatibility. Vardenafil ODT’s place in erectile dysfunction treatment is currently based largely on patient preference.