Allergan Inc said its Botox met the primary goals of a pair of late stage clinical trials for overactive bladder by significantly reducing episodes of urinary incontinence.

Based on the trial results, Allergan said it filed applications with US and European health regulators seeking the additional approval to treat adults suffering from overactive bladder who have not responded well to, or are intolerant of, anticholinergic drugs, such as Pfizer Inc's Detrol (tolterodine).

In both studies, Botox (onabotulinumtoxinA) led to a highly statistically significant decrease in the number of daily incontinence episodes compared with a placebo, the company said. The study involved patients whose condition was not caused by a neurological disorder.

Urinary tract infection common side effect

The study results were announced in conjunction with Allergan's Research and Development Technology review.

An estimated 3.2 million Americans with overactive bladder are taking oral anticholinergic drugs, Allergan said. It is believed that more than half of patients discontinue their medication due to inadequate response or intolerance to the drugs.

Treatment with Botox in the studies was well tolerated, with urinary tract infection among the most common side effects at a rate of 15% to 20% of patients, Allergan said.

(Reuters Health, March 2012) 

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