The approval of GELNIQUE is based on a Phase 3 randomized, double-blind, placebo-controlled, parallel group trial that evaluated a total of 789 patients with signs and symptoms of OAB. Over the 12-week trial, a one-gram, once-daily dose of GELNIQUE was superior to placebo at relieving OAB symptoms, including a reduction in incontinence episodes and urinary frequency, and an increase in urine void volume. The treatment was well tolerated in the study with a low incidence of adverse events and no treatment-related serious adverse events. The most frequently reported treatment-related adverse events (>2% and greater than placebo) were dry mouth (6.9%) and application-site reactions (5.4%).
Additional pharmacology studies showed that showering one hour or later, or the application of sunscreen 30 minutes before or after GELNIQUE application did not significantly alter the absorption of the drug.
For full prescribing information, please visit www.gelnique.com.
OAB is characterized by a sudden, uncomfortable need to urinate with or without urge incontinence (urine leakage), and usually includes more frequent urination and nocturia (waking up at least once during the night to urinate). It affects as many as 33 million adults in the U.S. - more than diabetes or asthma.
More than an "inconvenience," OAB is disabling and associated with a marked decrease in health-related quality of life as well as higher rates of dep
|SOURCE Watson Pharmaceuticals, Inc.|
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