- Company on Target to File NDA in Second Quarter of 2008 -
CORONA, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced positive results today from its Phase 3 study of oxybutynin topical gel (OTG) in patients with overactive bladder (OAB). The study met its primary endpoint of a statistically significant reduction in incontinence episodes, and secondary endpoints of reduction in frequency and increases in void volume compared with placebo, while demonstrating a low incidence of side effects.
"We are extremely encouraged with the results from this trial which will support our NDA submission, and we are on track to file with FDA in the second quarter of 2008," said Paul Bisaro, Watson's President and Chief Executive Officer. "Additionally, we have the potential to introduce the first gel formulation for the treatment of overactive bladder in 2009."
"Offering patients the ease and comfort of a daily gel for the treatment of OAB may provide greater patient acceptability and persistence on treatment," said Peter K. Sand, M.D., director of the Evanston Continence Center, Evanston Northwestern Healthcare, Northwestern University, Feinberg School of Medicine and Professor of Obstetrics and Gynecology and Director of the Division of Urogynecology, Evanston, IL.
It is well recognized that transdermal delivery of oxybutynin is a safe
and effective treatment for OAB. By delivering oxybutynin transdermally,
first-pass gastric and hepatic metabolism is bypassed, which is believed to
result in lower anticholinergic side effects such as dry mouth and
constipation. These side effects result in a significant level of patient
|SOURCE Watson Pharmaceuticals, Inc.|
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