Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Watson Pharmaceuticals has reported positive results from its multi-center, double-blind, placebo-controlled Phase III study of oxybutynin topical gel in patients with overactive bladder.
Subscribe to our email newsletter
The study has 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. Oxybutynin topical gel was well tolerated in the study. No serious adverse events related to the treatment were reported.
Paul Bisaro, Watson’s president and CEO, said: “We are extremely encouraged with the results from this trial which will support our new drug application submission, and we are on track to file with FDA in the second quarter of 2008. Additionally, we have the potential to introduce the first gel formulation for the treatment of overactive bladder in 2009.”