IRVINE, Calif.—Allergan Inc. announced recently that the U.S. Food and Drug Administration (FDA) has approvedBotox for the treatment of overactive bladder(OAB) with symptoms of urge urinary incontinence, urgency and frequencyin adults who have had an inadequate response to or are intolerant of ananticholinergic medication.
In two double-blind, randomized,multi-center, placebo-controlled 24-week clinical trials among adultswith overactive bladder who had not been adequately managed withanticholinergic treatments, Botox reportedly reduced daily urinary incontinenceepisodes as compared to placebo by 50 percent or more by week12 (reduction of 2.5 episodes from baseline of 5.5 episodes in one studyand reduction of 3 episodes from baseline of 5.5 episodes in the secondstudy for those treated with Botox vs. a reduction of 0.9 episodesfrom a baseline of 5.1 episodes in one study and a reduction of 1.1episodes from a baseline of 5.7 episodes in the second study for thosetreated with placebo).
"Allerganhas a long-standing commitment to study the potential of Botox totreat a number of different medical conditions," said Dr. Scott Whitcup,Allergan's executive vice president of research and development and chief scientific officer. "With today's approval, Botox is now approvedfor 26 different indications in more than 85 countries. Mostimportantly, today's FDA approval is a milestone in the treatment ofthis burdensome condition and will provide a novel option for urologistsand their OAB patients."
Whilethe exact cause is often unknown, OAB is a medical condition thatresults in an uncontrolled urge to urinate, frequent urination and, inmany patients, uncontrollable leakage of urine. In the United States, anestimated 14.7 million adults experience symptoms of OAB with urinaryincontinence (unexpected leakage of urine). Anticholinergics, which are often prescribed as pills, are used byapproximately 3.3 million Americans with OAB, with or without urinaryincontinence, to manage their condition. It is estimated, however, that greater than 50 percent of thesepatients stop taking at least one oral medication within 12 months,likely due to an inadequate response to, or intolerance of, themedication.
Among the other approved uses for Botox aside from the most famous, reducing the appearance of wrinkles, are the treatment of chronicmigraine,
post-stroke spasticity in the handand wrist, some types of facial spasms, cervical dystonia and excessive armpit sweating.