FDA approves broader OAB indication for botulinum

January 21, 2013

The FDA has expanded the approved use of onabotulinumtoxinA (Botox) to treat adults with overactive bladder who cannot use or do not adequately respond to anticholinergic medications.

The FDA has expanded the approved use of onabotulinumtoxinA (Botox) to treat adults with overactive bladder who cannot use or do not adequately respond to anticholinergic medications.

The safety and effectiveness of onabotulinumtoxinA for the new indication were established in two clinical trials of 1,105 patients with symptoms of overactive bladder. Patients were randomly assigned to receive injections of 100 units of the agent (20 injections of 5 units each) or placebo. At 12 weeks, results showed that patients treated with onabotulinumtoxinA experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. Treated patients also needed to urinate on average 1.0 to 1.7 times less per day and expelled an average of about 30 mL more urine than those treated with placebo.

Previously, the agent had been approved for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury or multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic drug.

"Overactive bladder can be a difficult condition to treat as there have been limited options for patients when currently available medications have failed to provide them with adequate relief," said Victor W. Nitti, MD, of NYU Langone Medical Center, New York. "With the approval of Botox, we have a new treatment option to offer these patients that has demonstrated efficacy in reducing urinary leakage and other symptoms of OAB with the effect lasting up to 6 months."

Common side effects reported during clinical trials included urinary tract infections, painful urination, and urinary retention. Patients who develop retention may need to use a catheter until the retention resolves. Patients being treated for overactive bladder should not have a urinary tract infection and should take antibiotics before, during, and for a few days after onabotulinumtoxinA treatment to lower the chance of developing a procedure-related infection.

Dr. Nitti received research support for conducting onabotulinumtoxinA clinical trials at NYU Langone and is a member of an Allergan advisory board.

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