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
'/>"/>

SOURCE VIVUS, Inc. Copyright©2010 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5
Related medicine technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
3. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
4. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
5. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
6. NeurogesX Announces Positive Results from Second Phase 3 Clinical Trial in Postherpetic Neuralgia
7. TAXUS WOMAN Study Reports Positive Clinical Outcomes for the TAXUS(R) Drug-eluting Stent in Women
8. Nabi Biopharmaceuticals Announces Continued Positive NicVAX Phase 2b Data at Nine Months
9. Kosans Second-Generation Hsp90 Inhibitor, Alvespimycin, Shows 42% Clinical Benefit in Phase 1 HER2-Positive Metastatic Breast Cancer Trial
10. Pharmacopeia Announces Positive Results from Phase 1 Multiple Ascending Dose Study of PS433540 (DARA)
11. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy