Intranasal vardenafil works faster than oral formulation for ED

Vardenafil (VDF), an effective treatment for erectile dysfunction, administered by an intranasal spray formulation achieves faster but similar plasma concentration with only about one-third dose relative to oral VDF tablet, according to a study.

Twelve healthy young volunteers participated in this single-dose randomized crossover study. Participants received VDF either as a 10-mg oral tablet or a 3.38-mg intranasal spray.

The authors obtained multiple blood concentrations and determined VDF concentrations using a liquid chromatography‒tandem mass spectrometry assay. They compared the pharmacokinetic parameters (ie, apparent elimination rate constant, elimination half-life, peak concentration, peak time, total area under the curve, and relative bioavailability) after each treatment and assessed the adverse events.

Parameters such as elimination rate constant, elimination half-life, peak concentration, and total are under the curve were similar between the two formulations, but the median peak time was shorter with the intranasal spray (10 vs 58 min; p<0.001).

Notably, there was less variability of the pharmacokinetic parameters with intranasal than oral administration. The relative bioavailability of intranasal to oral was 1.67.

In terms of safety, 50 percent of patients on intranasal VDF reported transient but tolerable local nasal reactions. Other side effects, such as headache, were comparable between the two formulations. However, the incidence of adverse events (AEs) was significantly less in the second treatment following initial VDF exposure. Serious AEs were not reported.

“Intranasal VDF potentially offers a more timely and lower dose for the treatment of ED in patients who can tolerate the transient local adverse reactions,” the authors said.