WASHINGTON (dpa-AFX) - Allergan Inc. (AGN) announced Friday that the U.S. Food and Drug Administration or FDA has approved BOTOX (onabotulinumtoxinA) for the treatment of overactive bladder or OAB with symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication.
When Botox is injected into the bladder muscle, it causes the bladder to relax, increasing the bladder's storage capacity and reducing episodes of urinary incontinence, the FDA said.
The company said while the exact cause is often unknown, OAB is a medical condition that results in an uncontrolled urge to urinate, frequent urination and, in many patients, uncontrollable leakage of urine. In the United States, an estimated 14.7 million adults experience symptoms of OAB with urinary incontinence or unexpected leakage of urine.
The FDA said that the results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. Botox-treated patients also needed to urinate on average 1.0 to 1.7 times less per day and expelled an average of about 30 milliliters more urine than those treated with placebo.
The FDA noted that the treatment with Botox can be repeated when the benefits from the previous treatment have decreased, but there should be at least 12 weeks between treatments.
Common side effects reported during clinical trials included urinary tract infections, painful urination, and incomplete emptying of the bladder (urinary retention). Patients who develop urinary retention may need to use a catheter until the urinary retention resolves.
Patients being treated for overactive bladder with Botox should not have a urinary tract infection and should take antibiotics before, during, and for a few days after Botox treatment to lower the chance of developing an infection from the procedure.
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