Navigation Links
QuatRx Announces Positive Results of Second Pivotal Phase 3 Clinical Study for Ophena(TM) (Ospemifene Tablets) in Treatment of Postmenopausal Vaginal Atrophy
Date:9/10/2009

ANN ARBOR, Mich., Sept. 10 /PRNewswire/ -- QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, today announced positive efficacy results from the second of two patient cohorts in the second pivotal Phase 3 study for Ophena(TM) (ospemifene tablets), the company's investigational compound in development for the treatment of postmenopausal vulvovaginal atrophy (VVA). This study, together with the recent completion of a long-term safety study for Ophena(TM), marks the end of the company's comprehensive Phase 3 efficacy and safety program for Ophena(TM) and positions QuatRx to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in early 2010.

This second phase 3 study of Ophena(TM) was a randomized, double-blind, placebo-controlled study with 919 women with vulvovaginal atrophy. The study was conducted at 116 sites in the United States. Among the cohort of 605 women in the study who identified dyspareunia as their most bothersome symptom, positive efficacy results were achieved in all four co-primary endpoints, including decrease in parabasal and superficial cells from vaginal smear, decrease in vaginal pH and improvement in the patient's most bothersome moderate to severe symptom of dyspareunia. The results showed highly statistically significant changes from baseline to week 12 compared to placebo in all four co-primary endpoints (p<0.0001). All women were supplied with a non-hormonal vaginal lubricant to be used as needed during the treatment period and the study results demonstrated efficacy above and beyond this lubricant usage, as also observed in the first Phase 3 study.

"These findings provide substantial additional evidence indicating the potential of Ophena(TM) to be a first-in-class non-estrogen drug for the treatment of vaginal atrophy," said Robert L. Zerbe, M.D., Chief Executive Offic
'/>"/>

SOURCE QuatRx Pharmaceuticals Company
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. QuatRx Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) in Postmenopausal Vaginal Atrophy
2. NBTY To Web Cast Presentation at CL King Best Ideas Conference; Announces Preliminary Unaudited Net Sales Results For August 2009
3. Sambazon Announces Scientific Advisory Board
4. Echo Therapeutics Announces New Presentation Time at Rodman & Renshaw 2009 Annual Global Investment Conference
5. DSS Research Announces Outbound Education and Verification Program Meets New CMS Requirements
6. Matrox Announces the New RAD LPX Series for Medical Imaging
7. Independence Blue Cross Announces Its Second Year Sponsorship of Step Out: Walk to Fight Diabetes
8. SCAN Health Plan Announces Expansion Into Northern California
9. Teva Womens Health Announces CopewithMenopause.com Relaunch Just in Time for Menopause Awareness Month
10. FiLife Announces New Twitter Contest on Fixing the American Healthcare System
11. Regado Biosciences Announces First Patient Enrolled in RADAR (Phase 2b) Study of REG1 Anticoagulation System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2015)... "Understanding Mental Disorders: Your Guide to the DSM-5®" ... Publishing, a division of the American Psychiatric Association. The ... Press Club in Washington, D.C.. The launch event will ... Paul Summergrad, MD. Guest speakers will include Former Congressman ... book; Paul Gionfriddo, President and CEO of Mental Health ...
(Date:4/27/2015)... April 27, 2015 UC Davis ... molecular basis of an inherited disorder that historically ... also arises in other populations of Semitic descent, ... series of elegant experiments, the researchers uncovered the ... leukodystrophy that is an incurable and progressively fatal ...
(Date:4/27/2015)... Fitness expert Samir Becic, four-time No. ... health and fitness revolution, teaming up with several celebrities ... several years, Houston, the fourth largest city in America, ... in America. With help from his friends, Becic aims ... the fittest and healthiest cities in the nation. , ...
(Date:4/27/2015)... Based in the Twin Cities of Minneapolis and ... insurance marketing organizations in the country focused on delivering ... as well as employer sponsored ancillary benefits. Spending two ... opportunity to consult with disability insurance carriers, helping to ... , An example of these programs include the most ...
(Date:4/27/2015)... April 27, 2015 On May 5, people ... ask their social media friends around the world to join ... asthma. , May 5 is World Pulmonary Hypertension Day ... leader in the global PH community, will take part in ... blood pressure of the lungs. PH is an increase in ...
Breaking Medicine News(10 mins):Health News:American Psychiatric Association, Patrick Kennedy To Debut New Consumer Guidebook “Understanding Mental Disorders” 2Health News:UC Davis Makes Breakthrough in Understanding Canavan Disease 2Health News:UC Davis Makes Breakthrough in Understanding Canavan Disease 3Health News:UC Davis Makes Breakthrough in Understanding Canavan Disease 4Health News:Houston Celebrities Take a Stand and Rebel Against Obesity 2Health News:Simplified Solutions Now Makes Disability Insurance Business With Secura Consultants Even Easier! 2Health News:Pulmonary Hypertension Association Marks World PH Day on May 5 with a Worldwide Lifesaving Social Media Blitz 2Health News:Pulmonary Hypertension Association Marks World PH Day on May 5 with a Worldwide Lifesaving Social Media Blitz 3
... Interoperability within ... Healthcare ... Technologies,Inc., a leading provider of integrated electronic health record ... the Healthcare Enterprise (IHE) Connectathon in Chicago.,The Connectathon, as ...
... Every Step Counts Organization in,association with Clear Channel ... will continue its efforts to celebrate survivors of,domestic ... "Walk In,Her Shoes" 2008, a unique designer shoe ... and Atlanta. Designer shoes featured in "Walk In ...
... electronic medical ... ... CERN ) and Hill-Rom, an operating company of Hillenbrand Industries,(NYSE: ... integrate their technologies to improve and coordinate healthcare,delivery, featuring Hill-Rom intelligent ...
... ... Information Mobility, PORTLAND, Ore., ... connectivity solutions, today announced the,first public demonstration of secure messaging ... HIMSS,(Healthcare Information and Management Systems Society) Conference. Connect,IQ(TM) for HealthVault ...
... Managed Care Contracts Provide 200,000 Members with In-network Access to ... ... MedCath Corporation,(Nasdaq: MDTH ), TexSAn Heart Hospital and the ... agreements with,Blue Cross and Blue Shield of Texas (BCBSTX)., The ...
... Supply chain management system enhanced to support multifaceted hospital, ... ... organization, ORLANDO, Fla., Feb. 25 HIMSS ,08 ... of system solutions to acute,healthcare facilities, today introduced its ...
Cached Medicine News:Health News:Greenway Medical Technologies Strengthens Industry Leadership With Participation in the IHE Connectathon and HIMSS Interoperability Showcase 2Health News:Greenway Medical Technologies Strengthens Industry Leadership With Participation in the IHE Connectathon and HIMSS Interoperability Showcase 3Health News:Greenway Medical Technologies Strengthens Industry Leadership With Participation in the IHE Connectathon and HIMSS Interoperability Showcase 4Health News:Shoe Therapy Helps Survivors Celebrate Life After Abuse 2Health News:Cerner Corporation and Hill-Rom Partner to Unify Hospital Care Delivery 2Health News:Cerner Corporation and Hill-Rom Partner to Unify Hospital Care Delivery 3Health News:Cerner Corporation and Hill-Rom Partner to Unify Hospital Care Delivery 4Health News:Cerner Corporation and Hill-Rom Partner to Unify Hospital Care Delivery 5Health News:Cerner Corporation and Hill-Rom Partner to Unify Hospital Care Delivery 6Health News:Kryptiq and Microsoft to Showcase Unprecedented Connectivity Between Consumers and Their Doctors at HIMSS '08 2Health News:Kryptiq and Microsoft to Showcase Unprecedented Connectivity Between Consumers and Their Doctors at HIMSS '08 3Health News:TexSAn Heart Hospital Signs Agreement with Blue Cross and Blue Shield of Texas 2Health News:Hospital Environments Increase Staff Efficiency and Patient Safety With Omnicell OptiFlex(TM) SS 9.0 2Health News:Hospital Environments Increase Staff Efficiency and Patient Safety With Omnicell OptiFlex(TM) SS 9.0 3
(Date:4/27/2015)... NxStage Medical, Inc. (Nasdaq: NXTM ), a ... Jeffrey H. Burbank , Chief Executive Officer, will present at ... Boston, MA on Thursday, May 7 th ... event will be made available at http://ir.nxstage.com   at ... NxStage Medical, Inc. (Nasdaq: NXTM ) is ...
(Date:4/27/2015)... Boston Scientific Corporation (NYSE: BSX ... leading software-driven medical technology company that helps improve ... provides patients and physicians a comprehensive portfolio for ... to treat a variety of disorders, and most ... such as Parkinson,s disease (PD), dystonia, and essential ...
(Date:4/27/2015)... 2015   Lexicon Pharmaceuticals, Inc. (Nasdaq: ... treatments for human disease, will release its first quarter ... the financial markets close.  Lexicon management will hold a ... and financial results for the first quarter 2015 at ... The dial-in number for the conference call is ...
Breaking Medicine Technology:NxStage to Present at the 40th Annual Deutsche Bank Securities Health Care Conference 2Boston Scientific Announces Strategic Collaboration With Brainlab AG 2Boston Scientific Announces Strategic Collaboration With Brainlab AG 3Boston Scientific Announces Strategic Collaboration With Brainlab AG 4Lexicon To Report First Quarter 2015 Financial Results On April 29, 2015 2
...  BioInformatics, LLC announces the pending release of three Q4 ... & Brand Assessment (#10-006) Exploring Structural Biology:  Tools ... Structure (#10-004) Genomic Technologies:  Market Insights for Life ... who provide product and services to these three rapidly ...
... Oct. 14 Octapharma USA ... Grants Program , which supports clinical or pre-clinical research ... therapy, intensive care and emergency medicine. The application deadline ... , one of the largest human protein products manufacturers ...
Cached Medicine Technology:BioInformatics, LLC New Market Reports - RNAi, Genomics and Membrane Protein Structure 2BioInformatics, LLC New Market Reports - RNAi, Genomics and Membrane Protein Structure 3BioInformatics, LLC New Market Reports - RNAi, Genomics and Membrane Protein Structure 4Octapharma Accepting Applications for Research Grants Focused on Human Protein Therapies 2
... The Brasseler USA™ Battery Packs contain ... age have a great impact upon battery ... is necessary. Any deviation from these recommendations ... are sensitive to heat. Any exposure of ...
Pneumatic High-speed Drill, Throttleless, 90k Rpm, Microaire Connector....
Pneumatic oscillating saw, 35k cpm, available with various hose connector styles....
Pneumatic micro reciprocating saw, 15k cpm, available with various hose connector styles....
Medicine Products: