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