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FDA approves Botox for incontinence

US healthcare regulator, the Food and Drug Administration, has approved Allergan's Botox injection for the treatment of urinary incontinence in people with neurological conditions who have an overactive bladder

US healthcare regulator, the Food and Drug Administration (FDA), has approved Allergan's Botox (onabotulinumtoxinA) injection for the treatment of urinary incontinence in people with neurological conditions who have an overactive bladder.

The neurotoxin, which has FDA approval for several other indications including chronic migraine and excessive sweating, can now be used to treat adults with conditions such as spinal cord injury (SCI) and multiple sclerosis (MS) who have an inadequate response to the standard anticholinergic medication for incontinence.

Neurological conditions, including SCI and MS, can cause overactivity in bladder muscles, leading to an inability to store urine. This condition affects 340,000 people in the US, according to Allergan.

Botox was approved for its new indication following two clinical studies involving 691 patients with SCI or MS. Both studies demonstrated significant decreases in the frequency of incontinence episodes in the Botox group compared with placebo.

George Benson, deputy director of the division of reproductive and urologic products at the FDA said: "Urinary incontinence associated with neurologic conditions can be difficult to manage. Botox offers another treatment option for these patients."

Dr Scott Whitcup, Allergan's chief scientific officer  and executive vice-president, research and development, said: "This approval of Botox is an important milestone in Allergan's commitment to develop and make available novel treatment options for urologists and their patients."

25th August 2011

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