Sep. 29, 2009 (PR Newswire) --

SAN FRANCISCO, Sept. 29 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leader in generic and specialty branded pharmaceuticals, announced findings of a double-blind study which demonstrate that GELNIQUE was comparable to placebo in its effect on memory tests and other cognitive functions in older healthy adult subjects when compared to immediate release oral oxybutynin treatments. The results were presented at the International Continence Society's Annual Meeting.

According to a recently published review article of randomized, double-blind, multi-center trials, oral oxybutynin was associated with cognitive deficit in four trials. This potential effect can be particularly concerning, given that more than half (57 percent) of the 34 million adult OAB sufferers in the U.S. are over the age of 60. GELNIQUE is the first and only topical gel for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency.

"Oxybutynin is a vital and effective treatment. That said, the potential for oral formulations to impact cognitive function is significant and weighs heavily on the treatment decisions I make on behalf of my OAB patients," said Scott MacDiarmid, MD, Director, Alliance Urology Specialists, Bladder Control and Pelvic Pain Center. "Topically administered oxybutynin gel is an effective and easy-to-use treatment option with very few anticholinergic side effects. I am comfortable and confident prescribing GELNIQUE with the added peace of mind these data offer in terms of cognitive safety."

Clinical Data

In the double-blinded, double dummy, Phase I study of 152 older, healthy, non-demented adults (average age of 68 years) from five U.S. centers, participants were randomized to one of three treatment arms for one-week of therapy: 1g GELNIQUE( )gel 10% once daily (GELNIQUE plus placebo oxybutynin immediate-release capsule; n=49); 5mg oral oxybutynin immediate-release three times daily (active OXB-IR capsules plus placebo GELNIQUE; n=52); or placebo (placebo GELNIQUE plus placebo OXB-IR capsules; n=51). After one week, participants were given a series of tests to assess cognitive and psychomotor functioning.

Results on the primary endpoint (Name-Face Association delayed recall) showed no significant treatment effect (p=0.273), as well as no significant differences versus placebo (GELNIQUE( )vs. placebo, p=0.155; OXB-IR vs. placebo, p=0.177).