Eighty percent (80%) of sexual attempts among patients on avanafil had erections sufficient for intercourse (SEP2)Sixty-seven percent (67%) of patients taking avanafil experienced successful intercourse (SEP3)Successful intercourse was achieved as early as 15 minutes after dosingAvanafil was well tolerated as evidenced by a low rate of discontinuations due to adverse events (2.8%) The most common side effects reported were headache (5.6%), flushing (3.5%), nasopharyngitis (3.4%) and nasal congestion (2.1%)There were no drug-related serious adverse events reported in the study
Patients achieved an overall improvement in erectile function, as measured by the erectile function (EF) domain score of the International Index of Erectile Function (IIEF). EF domain scores range from 0-30 and measure erectile function as follows: severe dysfunction is less than or equal to 10; moderate dysfunction is 11-16; mild/minimal dysfunction is 17-25; with normal function in the range of 26-30. At baseline, patients in the study had a mean EF domain score of 12.3 (high moderate). At the end of treatment, patients in the study had a mean EF domain score of 22.6, representing a change from baseline of 10.3.
SOURCE VIVUS, Inc.