Navigation Links
VIVUS Announces Positive Phase 3 Results of Avanafil in Radical Prostatectomy Patients
Date:5/25/2011

nal study report will be submitted to the FDA upon completion.  VIVUS expects to file the NDA for avanafil in the second quarter of 2011.

About the StudyTA-303 was a randomized, double-blind, placebo-controlled, parallel group, multicenter study of the safety and efficacy of avanafil in the treatment of erectile dysfunction following bilateral, nerve-sparing, radical prostatectomy in 298 men with ED.  On average, subjects entering the study were 58 years old, 19 months past their surgery dates and diagnosed with severe ED.  Subjects were randomized to 100mg or 200mg avanafil or placebo and were instructed to take one dose of study drug 30 minutes prior to initiation of sexual activity.  The study had a four-week run-in period followed by 12 weeks of treatment.  The primary endpoints of the study were improvement in erectile function as measured by the SEP2 and SEP3 and improvements in the EF-Domain of the IIEF score; secondary endpoints included patient satisfaction with erections and with sexual experience.

About the Avanafil Phase 3 ProgramIn addition to TA-303, the avanafil phase 3 program consists of three pivotal studies:  TA-301 (REVIVE), TA-302 (REVIVE-Diabetes), and TA-314. TA-301 and TA-302 were randomized, double-blind, placebo-controlled phase 3 studies of avanafil in 646 and 390 men, respectively, with a history of ED for at least six months. Each of these trials had 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 as early as 15 minutes after dosing. TA-314 was an open
'/>"/>

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

Page: 1 2 3 4 5

Related biology technology :

1. VIVUS Reports First Quarter 2009 Financial Results and Highlights
2. Data on VIVUS Qnexa To Be Presented During Two Podium Presentations at ADA Annual Meeting
3. VIVUS to Present at the Needham and Company Life Sciences Conference
4. VIVUS to Present at the Canaccord Adams 29th Annual Global Growth Conference
5. VIVUS to Present at Four Upcoming Healthcare Conferences
6. VIVUS Announces Positive Results From Two Phase 3 Studies; Obese Patients on Qnexa Achieve Average Weight Loss up to 14.7% and Significant Improvements in Co-Morbidities
7. VIVUS Reports Third Quarter 2009 Highlights and Financial Results
8. VIVUS to Present at Two Upcoming Investor Conferences
9. VIVUS to Present at Four Upcoming Investor Conferences
10. Data on VIVUS QNEXA to be Presented in Six Posters at The Obesity Societys Annual Meeting
11. VIVUS to Present at the 10th Annual Needham Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 23, 2014 Pipette.com announces their ... followers can submit their #HolidayInTheLab pictures for a chance ... mates. , For those struggling to think of a ... Holiday in the Lab Contest provides the ideal holiday ... to send pictures of their chemistree, holiday sweaters, ...
(Date:12/24/2014)... Dec. 23, 2014 Sigma-Aldrich Corporation (NASDAQ: ... waiting period under the Hart-Scott-Rodino Antitrust Improvements Act ... on December 22, 2014, thereby completing the U.S. ... the acquisition of the Company by Merck KGaA, ... satisfies another condition to closing the transaction, which ...
(Date:12/22/2014)... , Dec. 22, 2014   Synthetic ... developer of pathogen-specific therapies for serious infections ... the microbiome, today announced positive topline safety ... clinical trial of SYN-004, the Company,s investigational ... Clostridium difficile (C. difficile) infection, ...
(Date:12/22/2014)... , Dec. 22, 2014  ( www.competitivehealth.com ) ... an online medical bill review and advocacy service, has ... the FREE WellCard Savings discount health services marketplace. ... that was more than they expected to pay. As ... health care costs, WellCard Savings is pleased to offer ...
Breaking Biology Technology:Major Pipette Distributor Pipette.com Announces their Holiday in the Lab Contest 2Acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany, Receives U.S. Antitrust Clearance 2Acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany, Receives U.S. Antitrust Clearance 3Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection 2Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection 3Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection 4Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection 5WellCard Savings Announces CoPatient Medical Bill Review Service for Members 2
... , LAUSANNE, Switzerland and ... Swiss-based global biopharmaceutical group,of companies with a focus ... medical needs, and MSM Protein Technologies (MSM), a ... in targeting,multi-spanning membrane proteins, announce the signature of ...
... ... standard gas stick that can be shipped from stock greatly minimizing lead times for ... ... based firm specializing in process controls for the delivery of critical fluids, introduces an ...
... class of economically viable solar power cellscheap, flexible and ... as a result of recent work* at the National ... deepened their understanding of the complex organic films at ... rely on organic molecules to capture sunlight and convert ...
Cached Biology Technology:Debiopharm and MSM Protein Technologies Sign Agreement for Research and Development of Debio 0929, a Novel Oncology Biologic 2Debiopharm and MSM Protein Technologies Sign Agreement for Research and Development of Debio 0929, a Novel Oncology Biologic 3Debiopharm and MSM Protein Technologies Sign Agreement for Research and Development of Debio 0929, a Novel Oncology Biologic 4Aztech Controls Introduces Standardized Gas Sticks for Semiconductor Tool Hook Up 2Aztech Controls Introduces Standardized Gas Sticks for Semiconductor Tool Hook Up 3NIST scientists study how to stack the deck for organic solar power 2
(Date:12/10/2014)... , Dec. 9, 2014  Wake Forest Baptist Medical Center ... for its School of Medicine. Funding for this $50 ... campaign that will be publicly launched next summer. ... in the former 60 series R.J. Reynolds Tobacco Company ... Construction will begin immediately with plans to be ready ...
(Date:12/10/2014)... , Dec. 08, 2014 Research and Markets ... addition of the "Biometrics Market in Japan ... http://photos.prnewswire.com/prnh/20130307/600769 The ... such as rural banking and upgradation of the ... witnessed in the market. Besides the aforementioned projects, ...
(Date:12/5/2014)... 4, 2014 Increased emphasis on product ... new testing and inspection technologies. The convergence of ... a range of innovative test solutions. This trend ... Y, which is generally more inclined towards communication, ... development strategies of test equipment vendors will cater ...
Breaking Biology News(10 mins):Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 2Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 3Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 4Biometrics Market in Japan 2014-2018: Key Vendors are DDS, Fujitsu, Hitachi and NEC 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 3Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 4
... at the University of Liverpool have discovered that the ... million years old and took its present shape about ... in collaboration with the University of Amsterdam and Petrobras, ... taken from two boreholes near the mouth of the ...
... well-fed, clonal organisms in the Caribbean Sea as the ... Pacific, report researchers from the Smithsonian Tropical Research Institute ... shows that if a species could shift from clonal ... for extinction, millions of years later. Closure of the ...
... A study conducted by researchers at Ben-Gurion University of the ... indicates that approximately 16 percent of public health care workers ... regardless of the severity. The study,just published in the ... 1,835 public health workers in Minnesota, Ohio and West Virginia ...
Cached Biology News:Sex in the Caribbean: Environmental change drives evolutionary change -- eventually 21 in 6 health workers won't report in flu pandemic -- study by Ben-Gurion U. researchers 21 in 6 health workers won't report in flu pandemic -- study by Ben-Gurion U. researchers 3
... Molecular Imaging's proprietary Focus™ detector technology, while ... the R4. The microPET Focus 120 ... avaiable PET scanner. Focus scanners also ... scinitallor based PETsystems. The combination of ...
... The Freedom EVO series offers versatile ... to successfully automate a wide variety of ... in four different base sizes (75, 100, ... personnel access to a platform that will ...
... This product has been developed to significantly ... labeled proteins. Stability is increased at ... 2-8 centigrade. This product is subjected ... mercury or azide. This formulation insures ...
... The StatMatic I provides a convenient and ... culture work. Used with an eight-port disposable ... not possible with multi-channel pipettes. The eight-port ... in volumes of 100, 200, 250, or ...
Biology Products: