Pharmacokinetics comparison of vardenafil as administered by an intranasal spray formulation vs a 10-mg oral tablet.

This article focuses on a pilot clinical study comparing the pharmacokinetics and safety of vardenafil (VDF) administered via an intranasal spray formulation (SDS089) versus a 10-mg oral tablet for the treatment of erectile dysfunction (ED). The study, conducted in 12 healthy young male volunteers using a randomized crossover design, found that intranasal VDF achieved a significantly faster median peak plasma concentration time (Tmax of 10 minutes vs. 58 minutes for oral), higher relative bioavailability (1.67-fold), and similar peak concentration (Cmax) compared to oral administration. While intranasal dosing caused more transient local nasal adverse events (e.g., sneezing, nasal discomfort), these were generally tolerable and decreased upon repeated exposure; no serious adverse events were reported. The findings suggest that intranasal VDF may offer a more rapid and lower-dose treatment option for ED patients who can tolerate local nasal effects, though further studies in broader populations and with multiple dosing are needed to confirm safety and efficacy.