Navigation Links
Phase II Clinical Trial Results Encouraging for PA-Based Women's Health Company
Date:1/11/2011

WAYNE, Pa., Jan. 11, 2011 /PRNewswire/ -- FemmePharma Global Healthcare, a privately held women's health company dedicated to improving the quality of life for women, today announces completion of its Phase II clinical dose ranging/safety trial with FP 1097 in women suffering from urinary incontinence or overactive bladder (OAB).

The Phase II FP 1097 trial demonstrated that drug can be delivered to the bladder via intra-vaginal administration successfully. The clinical trial showed a statistically significant 25 percent reduction of micturitions and a 75 percent reduction of incontinence episodes. Treatment-related adverse events were low with no serious adverse events and all subjects completing the trial. Over 50 percent of the patients on FP 1097 achieved total continence.

Based on the results, FemmePharma Global Healthcare was granted permission to proceed to a pivotal Phase III trial by the Food and Drug Administration (FDA). In addition the FDA will grant FemmePharma 505B1 filing status for FP 1097.

According to published reports, it is estimated that more than 30 million Americans (mostly women) experience OAB. IMS Healthcare estimates that the OAB prescription market in the United States exceeds $2.0 billion annually while the total worldwide market including drugs, diapers and devices exceeds $7.0 billion annually.

"The encouraging safety and efficacy results from this randomized study of FP 1097 provides a basis to advance this innovative product into Phase III clinical development," said Gerianne DiPiano, founder, President and CEO of FemmePharma Global Healthcare, Inc.


'/>"/>
SOURCE FemmePharma Global Healthcare
Copyright©2010 PR Newswire.
All rights reserved

Page: 1

Related biology technology :

1. Enobia Announces Successful Completion of Phase II Juvenile Study of ENB-0040, a Bone Targeted Enzyme Replacement Therapy
2. Ardea Biosciences Announces Positive Top-Line Results from Phase 2b Combination Study of RDEA594 in Allopurinol-Refractory Gout Patients
3. MacroGenics Initiates Phase I Clinical Trial of MGAH22 for Patients With HER2-Expressing Solid Tumors
4. Juventas Therapeutics Initiating Phase II Clinical Trial of JVS-100 for Treatment of Critical Limb Ischemia
5. Tolerx Initiates Phase 1 Clinical Trial of TRX518, a First-in-Class anti-GITR Antibody for the Treatment of Cancer
6. Spherix Phase 2 Trial with D-tagatose Determines Minimum Dose for HbA1c and Triglycerides
7. GeNO LLC Initiates Phase 2 Trial For Nitric Oxide Delivery System
8. Onyx Pharmaceuticals Announces Positive Complete Results From Carfilzomib Phase 2b Study
9. YM BioSciences Reports Positive Interim Data Including Substantial Anemia Response from Phase I/II Trial of JAK1/JaK2 Inhibitor CYT387
10. Early Safety Results Promising for Phase I/II Trial of Gene Therapy Treatment of Hemophilia B
11. Oncothyreon Reports Positive Data from Phase 1 Clinical Trial of PI3-Kinase Inhibitor PX-866 in Patients with Relapsed or Refractory Solid Tumors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/23/2017)... ... 2017 , ... Having proven that its Disruptor™ technology is ... Green Cell Technologies® (GCT®), has turned its attention to the lucrative ... ‘pressing’ methods, ushering in a new era of modern, cost effective and more ...
(Date:8/22/2017)... ... August 22, 2017 , ... One of the biggest ... of opioid-dose sparing. Opioid-dose sparing refers to the reduction of opioid dosage by ... anti-inflammatory drugs (NSAIDs). , The potential for new therapies to replace opioids and/or ...
(Date:8/21/2017)... ... August 21, 2017 , ... Baltimore biotech firm, PathSensors, ... to bring its proprietary CANARY pathogen detection technology and high throughput testing solutions ... has purchased an undisclosed number of PathSensors’ Zephyr pathogen detection instruments and will ...
(Date:8/18/2017)... San Jose, CA (PRWEB) , ... August 18, ... ... of advanced precision Lithography Equipment for the Semiconductor, MEMS, and Microfluidics Industries, announces ... offers features and specifications found more often in automated production mask aligners. OAI ...
Breaking Biology Technology:
(Date:3/30/2017)... , March 30, 2017  On April 6-7, ... Hack the Genome hackathon at Microsoft,s headquarters ... two-day competition will focus on developing health and wellness ... Hack the Genome is the first ... tremendous. The world,s largest companies in the genomics, tech ...
(Date:3/28/2017)... -- The report "Video Surveillance Market by ... Devices), Software (Video Analytics, VMS), and Service (VSaaS, Installation ... 2022", published by MarketsandMarkets, the market was valued at ... reach USD 75.64 Billion by 2022, at a CAGR ... considered for the study is 2016 and the forecast ...
(Date:3/23/2017)... report "Gesture Recognition and Touchless Sensing Market by Technology (Touch-based and Touchless), Product ... by MarketsandMarkets, the market is expected to be worth USD 18.98 billion by ... Continue Reading ... ...      (Logo: http://photos.prnewswire.com/prnh/20160303/792302) ...
Breaking Biology News(10 mins):