Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Virgo Health

Virgo Health is an award-winning global healthcare communications and medical education agency comprising specialists with some of the best skills,...

Latest intelligence

The UK’s new five-year pricing agreement
Pharma has agreed to capped growth again - in exchange for uptake promises...
Digital applications are transforming the market access landscape
Organisations are leveraging new technology to implement a wider range of business models and, in essence, drive market access success by working smarter, faster and with greater economy....
Escaping the spin cycle of sub-optimal launch
...

Infographics