The investigational drug, avanafil, is a highly selective, orally administered phosphodiesterase type 5 (PDE5) inhibitor being developed by the company to treat erectile dysfunction (ED).
The trial is a multi-center, double-blind, randomized, placebo-controlled, parallel-design clinical study that has enrolled 298 patients. The purpose of this study is to evaluate the safety and efficacy of a number of different doses of avanafil with the goal of selecting the appropriate doses for phase III clinical trials.
Previous studies with avanafil have demonstrated a rapid onset of action and a half-life of 60-90 minutes. Vivus Inc intends to announce results upon completion of the trial, which is expected to be later this year.
Vivus Inc is focused on research, development and commercialization of products proven to restore sexual function in both men and women. The company has strategic alliances with pharmaceutical companies for development and commercialization of products in this area, with partners including Meda AB, Paladin Labs, and Tanabe Seiyaku Co.