March 28, 2012 / 1:00 PM / 7 years ago

Allergan Botox works in overactive bladder studies

* Says Botox significantly decreased incontinence vs placebo

* Says filed for U.S., Europe supplementary approvals

March 28 (Reuters) - 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, creating another potentially lucrative revenue source for the wrinkle treatment.

Based on the trial results, Allergan said it filed applications with U.S. 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.

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

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

Botox, which is administered by injection, had sales of $1.6 billion in 2011, primarily as a treatment for facial wrinkles.

But it is also approved for several other uses, including migraine headaches, eye muscle disorders, upper limb spasticity and as a treatment for urinary incontinence caused by neurological disorders, such as spinal injuries and multiple sclerosis.

An estimated 3.2 million Americans with overactive bladder are taking oral medications from the class called anticholinergics, Allergan said.

It is believed that more than half of patients discontinue their medication due to inadequate response or intolerance to the drugs, creating a market for Botox.

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 percent of patients, Allergan said.

Symptoms of overactive bladder include uncontrolled urge to urinate, frequent urination and uncontrolled urinary leakage.

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