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:10/11/2017)...  VMS BioMarketing, a leading provider of patient support solutions, ... Educator (CNE) network, which will launch this week. The VMS ... care professionals to enhance the patient care experience by delivering ... health care professionals to help women who have been diagnosed ... ...
(Date:10/11/2017)... ... ... Disappearing forests and increased emissions are the main causes of the evolving air ... living in larger cities are affected by air pollution related diseases. , That is ... globally - decided to take action. , “I knew I had to take action ...
(Date:10/11/2017)... Bay, Florida (PRWEB) , ... October 11, 2017 ... ... and Drug Administration (FDA) has granted orphan drug designation to SBT-100, its novel ... (sdAb) for the treatment of osteosarcoma. SBT-100 is able to cross the cell ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... targeted antibody-drug conjugate (ADC) therapeutics, today confirmed licensing rights that give it ... Nanoparticle), a technology developed in collaboration with Children’s Hospital Los Angeles (CHLA). ...
Breaking Biology Technology:
(Date:4/11/2017)... N.Y. , April 11, 2017 ... fingerprints, but researchers at the New York University ... College of Engineering have found that partial similarities ... security systems used in mobile phones and other ... thought. The vulnerability lies in the ...
(Date:4/6/2017)... 6, 2017 Forecasts by Product ... Readers, by End-Use (Transportation & Logistics, Government & Public ... & Fossil Generation Facility, Nuclear Power), Industrial, Retail, Business ... Are you looking for a definitive report on ... ...
(Date:4/5/2017)... , April 5, 2017 Today HYPR ... that the server component of the HYPR platform is ... providing the end-to-end security architecture that empowers biometric authentication ... HYPR has already secured over 15 million users across ... manufacturers of connected home product suites and physical access ...
Breaking Biology News(10 mins):