VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from TA-314, a phase 3 pivotal open-label safety study of avanafil, an investigational drug for the treatment of erectile dysfunction (ED). The study met all primary endpoints by demonstrating improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP2 and SEP3) and improvements in the International Index of Erectile Function (IIEF). In the study, patients treated with avanafil who attempted sexual intercourse (SEP3) within the first 15 minutes of dosing had success rates of 80%.
"TA-314 confirms the longer term safety and efficacy results observed in the previously reported placebo-controlled phase 3 studies of avanafil in patients with ED. The open label design allowed the over 700 enrolled patients to use avanafil as needed and at a dose of their choosing," stated Leland Wilson, chief executive officer of VIVUS. "With the completion of this study, we continue to anticipate the completion of the NDA filing for avanafil in the second quarter of 2011."
Highlights of the study include:
- 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 dosing
- Avanafil 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.