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:2/4/2016)... ... , ... Many of the engineers at FireflySci, Inc. have been manufacturing quartz ... from other cuvette manufacturers is their supercharged customer service and their extensive database of ... steady flow of inside information, they have recently revamped their manufacturing techniques to reduce ...
(Date:2/3/2016)... WARRINGTON, Pa. , Feb. 3, 2016 /PRNewswire/ ... biotechnology company focused on developing aerosolized KL4 surfactant ... Board of Directors has approved an inducement award ... Craig Fraser , its newly appointed President and ... the Board,s Compensation Committee on February 1, 2016 ...
(Date:2/3/2016)... Feb. 3, 2016 Ascendis Pharma A/S (Nasdaq: ... applies its innovative TransCon technology to address significant unmet ... upcoming investor conference.Event:2016 Leerink Partners Global Healthcare Conference Location: ... Wednesday, February 10, 2016 Time:  , 11:55am EST ... --> An audio webcast of this event ...
(Date:2/3/2016)... Feb. 3, 2016 New Jersey Health Foundation ... $1 million for researchers in New ... research that demonstrates exciting potential.   ... for the New Jersey Health Foundation Research Grant ... these educational institutions— Princeton University, Rutgers University, Rowan ...
Breaking Biology Technology:
(Date:1/20/2016)... SAN JOSE, Calif. , Jan. 20, 2016 ... leading developer of human interface solutions, today announced ... touch controller solution for wearables and small screen ... appliances such as printers. Supporting round and rectangular ... the S1423 offers excellent performance with moisture on ...
(Date:1/13/2016)... ALBANY, New York , January 13, 2016 /PRNewswire/ ... Transparency Market Research has published a new market report ... Share, Growth, Trends, and Forecast, 2015 - 2023. According to ... mn in 2014 and is anticipated to reach US$1,625.8 ... from 2015 to 2023. In terms of volume, the ...
(Date:1/11/2016)... 11, 2016  higi, the leading retail and ... locations, web and mobile, today announced it has ... existing investors. --> ... further innovate higi,s health platform – its network ... – including expanding services and programs to retail ...
Breaking Biology News(10 mins):