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Positive Results from Long-Term Phase 3 Study of Avanafil Featured at American Urological Association Annual Meeting
Date:5/17/2011

sly used other oral ED therapies. Each of these trials has a similar trial design with patients undergoing a four-week, non-treatment run-in period followed by 12 weeks of treatment. Primary endpoints of the studies are improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the EF domain score of the International Index of Erectile Function (IIEF). In both the TA-301 and TA-302 studies, all doses of avanafil met the primary endpoints, with successful intercourse achieved by some subjects in 15 minutes or less after administration. TA-314 was an open label, long-term safety and efficacy study required as part of the NDA.  In TA-314, patients also had significant improvement in erectile function as measured by SEP2, SEP3 and IIEF. 

VIVUS has also held a pre-NDA meeting with the FDA to confirm that the pre-clinical and clinical requirements necessary for the filing of an NDA have been met. In total, the phase 3 avanafil clinical program enrolled approximately 1,350 subjects. VIVUS expects to file the NDA for avanafil in the second quarter of 2011.

About Erectile Dysfunction (ED)Erectile Dysfunction (ED) is defined as the inability to attain and maintain an erection sufficient for sexual intercourse. According to the Massachusetts Male Aging Study (MMAS), ED affects an estimated 52 percent of men between the ages of 40 and 70. The prevalence of ED increases with age and can be affected by a variety of factors, including certain medications such as anti-hypertensives and histamine receptor antagonists; lifestyle, such as tobacco or alcohol use; diseases, including diabetes and cardiovascular conditions; and spinal cord injuries. Studies have shown that up to 58% of men with diabetes have erectile dysfunction.

About VIVUS VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigat
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SOURCE VIVUS, Inc.
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