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If an overactive bladder keeps you from staying as active as you'd like to be, this new treatment might be worth looking into. I could have used this stuff on the ski slopes this past weekend. You should have seen me screaming to the bathroom! - Dave
FDA Approves Oxybutynin Chloride Gel for the Treatment of Overactive Bladder
NEW YORK -- January 27, 2009 -- The US Food and Drug Administration (FDA) has approved oxybutynin chloride (Gelnique) Gel 10% for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency.
Because the active ingredient in the gel is delivered transdermally, it is not metabolised by the liver in the same way as orally administered oxybutynin. This results in a low level of side effects, such as dry mouth and constipation.
The approval is based on a phase 3 randomised, 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 1-gram, once-daily dose of oxybutynin chloride gel 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 1 hour or later, or the application of sunscreen 30 minutes before or after applying the gel did not significantly alter the absorption of the drug.
SOURCE: Watson Pharmaceuticals, Inc.
FDA Approves Oxybutynin Chloride Gel for the Treatment of Overactive Bladder
NEW YORK -- January 27, 2009 -- The US Food and Drug Administration (FDA) has approved oxybutynin chloride (Gelnique) Gel 10% for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency.
Because the active ingredient in the gel is delivered transdermally, it is not metabolised by the liver in the same way as orally administered oxybutynin. This results in a low level of side effects, such as dry mouth and constipation.
The approval is based on a phase 3 randomised, 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 1-gram, once-daily dose of oxybutynin chloride gel 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 1 hour or later, or the application of sunscreen 30 minutes before or after applying the gel did not significantly alter the absorption of the drug.
SOURCE: Watson Pharmaceuticals, Inc.
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