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:10/10/2017)... ... October 10, 2017 , ... For the ... won a US2020 STEM Mentoring Award. Representatives of the FirstHand program travelled to ... Experience from US2020. , US2020’s mission is to change the trajectory of STEM ...
(Date:10/10/2017)... , Oct. 10, 2017 SomaGenics announced ... the NIH to develop RealSeq®-SC (Single Cell), expected to ... profiling small RNAs (including microRNAs) from single cells using ... highlights the need to accelerate development of approaches to ... "New techniques for measuring levels of ...
(Date:10/9/2017)... DIEGO , Oct. 9, 2017  BioTech ... biological mechanism by which its ProCell stem cell ... critical limb ischemia.  The Company, demonstrated that treatment ... amount of limbs saved as compared to standard ... the molecule HGF resulted in reduction of therapeutic ...
(Date:10/9/2017)... Arizona (PRWEB) , ... October 09, 2017 , ... ... Kindred, a four-tiered line of medical marijuana products targeting the needs of consumers ... and packaging of Kindred takes place in Phoenix, Arizona. , As operators of ...
Breaking Biology Technology:
(Date:4/18/2017)...  Socionext Inc., a global expert in SoC-based imaging and computing ... M820, which features the company,s hybrid codec technology. A demonstration utilizing ... Inc., will be showcased during the upcoming Medtec Japan at Tokyo ... Las Vegas Convention Center April 24-27. ... Click here for an image ...
(Date:4/13/2017)... MONICA, Calif. , April 13, 2017 ... New York will feature emerging and evolving ... Summits. Both Innovation Summits will run alongside the expo ... of speaker sessions, panels and demonstrations focused on trending ... coast,s largest advanced design and manufacturing event will take ...
(Date:4/11/2017)... , April 11, 2017 Crossmatch®, a ... authentication solutions, today announced that it has been ... Research Projects Activity (IARPA) to develop next-generation Presentation ... "Innovation has been a driving force ... program will allow us to innovate and develop ...
Breaking Biology News(10 mins):