Regulators in the USA have given the green light to Allergan's Botox, best-known for wrinkles, as a treatment to help bladder control.
The US Food and Drug Administration has approved Botox (onabotulinum toxin A) for overactive bladder (OAB) with symptoms of urinary incontinence, urgency and frequency in adults who do not respond to an anticholinergic, such as Pfizer's Detrol (tolterodine). The positive opinion is based on the results of two Phase III trials involving over 1,100 patients; targeted injections of Botox into the bladder muscle reduced daily urinary incontinence episodes by 50% or more compared to placebo by week 12.
Scott Whitcup, Allergan’s chief scientific officer, noted that Botox is now approved for 26 different indications in more than 85 countries. He claimed that the latest thumbs-up, which follows European approval granted in December, "is a milestone in the treatment of this burdensome condition and will provide a novel option for urologists and their OAB patients".
In the USA, some 14.7 million adults experience symptoms of OAB with urinary incontinence and anticholinergics, which are often prescribed as pills, are used by 3.3 million Americans. It is estimated, however, that greater than 50% of these patients stop taking at least one oral medication within 12 months, likely due to an inadequate response to, or intolerance of, the drug.
As well as being a wrinkle smoother, Botox is also used for a number of other indications, including chronic migraine, certain facial spasms, cervical dystonia, excessive sweating of the armpits and the treatment of post-stroke spasticity in the hand and wrist.