BOTOX Receives FDA Approval for Overactive Bladder

The US FDA just approved BOTOX (onabotulinumtoxinA) from Allergan, Inc. for the treatment of overactive bladder (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. In two double-blind, randomized, multi-center, placebo-controlled 24-week clinical trials among adults with OAB who had not been adequately managed with anticholinergic treatments, BOTOX reduced daily urinary incontinence (leakage) episodes as compared to placebo by 50 percent or more by week 12 (reduction of 2.5 episodes from baseline of 5.5 episodes in one study and reduction of 3 episodes from baseline of 5.5 episodes in the second study for those treated with BOTOX vs. a reduction of 0.9 episodes from a baseline of 5.1 episodes in one study and a reduction of 1.1 episodes from a baseline of 5.7 episodes in the second study for those treated with placebo). BOTOX treatment relieves OAB symptoms by temporarily calming muscle contractions by blocking the transmission of nerve impulses to the bladder muscle.