OBJECTIVES: Avanafil is a highly selective phosfosdiesterase 5 inhibitor (PDE5 
inhibitor), with rapid onset of action, approved by the Food and Drug 
Administration (FDA) and the European Medicines Agency for the treatment of 
erectile dysfunction (ED). It had been recently commercialized in Spain. This 
article presents a detailed review of the available literature, where the 
safety, tolerability and efficacy of avanafil were evaluated.
METHODS: A systematic literature search using the Medline database was 
performed. The search included the terms Avanafil and erectile dysfunction. The 
pivotal studies of clinical development of the drug, and also those randomized, 
double-blind, placebo-controlled, well-designed studies were analyzed. We 
included those studies published in English up to January 2014. Likewise, 
studies of the pharmacokinetics and pharmacodynamics of the drug were also 
included.
RESULTS: The avanafil pivotal studies, conducted in general population of 
patients with ED, patients with Diabetes mellitus type I and II and patients 
with ED secondary to nerve sparing radical prostatectomy were analyzed. In all 
these studies, avanafil demonstrated a statistically significant improvement in 
erectile function (IIEF), and all the coprimary outcomes (SEP2 and SEP3) 
compared to placebo. Also, a good tolerance profile and few side effects 
compared to placebo were evident.
CONCLUSIONS: Avanafil is a selective PDE5 inhibitors, that is rapidly absorbed 
and that has a short time to peak response. It found to be effective in 
randomized, double-blind, placebo-controlled trials conducted in men with 
erectile dysfunction, including in patients with diabetes mellitus and after 
radical prostatectomy. It was generally well tolerated across trials, with very 
few patients withdrawing because of adverse effects. Similarly, avanafil had a 
significantly lower rate of hemodynamic side effects compared with sildenafil.