The FDA has approved a new, once-daily drug to treat overactive bladder (search), an often embarrassing disorder that affects up to 20 million men and women in the U.S.
Vesicare (search) is approved to treat overactive bladder with symptoms of urgency, frequency, and urge incontinence.
In people with overactive bladder, one of the muscles that surrounds the bladder contracts spastically. People with the condition experience an urge to urinate more frequently and often without warning, and lose control of urine before reaching a restroom.
The symptoms of overactive bladder include:
Urgency: an immediate and strong urge to urinate
Frequency: the need to frequently urinate
Urge incontinence: involuntary loss of urine.
The FDA based its approval on the results of four clinical trials involving 3,000 people with these symptoms.
The studies showed that the 5-milligram and 10-milligram doses both significantly improved all major symptoms of overactive bladder.
For example, the number of incontinence episodes was reduced among those taking Vesicare versus the placebo in a 12-week study.Vesicare demonstrated 24-hour control of overactive bladder symptoms.
The most commonly reported side effects of Vesicare were dry mouth, constipation, and blurred vision.
Vesicare should not be used by people with uncontrolled narrow-angle glaucoma, and in those with retention of urine or gastric retention, or those with abnormal kidney or liver function.
SOURCE: News release, Yamanouchi Pharmaceutical Co., Ltd and GlaxoSmithKline.