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FDA Approves Allergan Inc. (AGN)'s Botox to Treat Specific Form of Urinary Incontinence


8/25/2011 6:31:17 AM

SILVER SPRING, Md., Aug. 24, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder.

The treatment consists of Botox being injected into the bladder resulting in relaxation of the bladder, an increase in its storage capacity and a decrease in urinary incontinence.

"Urinary incontinence associated with neurologic conditions can be difficult to manage," said George Benson, deputy director, Division of Reproductive and Urologic Products. "Botox offers another treatment option for these patients."

Injection of the bladder with Botox is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder. Cystoscopy may require general anesthesia. The duration of the effect of Botox on urinary incontinence in patients with bladder overactivity associated with a neurologic condition is about nine months.

The effectiveness of Botox to treat this type of incontinence was demonstrated in two clinical studies involving 691 patients. The patients had urinary incontinence resulting from spinal cord injury or multiple sclerosis. Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox group compared with placebo.

In addition to its use to improve the appearance of facial frown lines, Botox also is FDA-approved to treat chronic migraine headaches, certain kinds of muscle stiffness and contraction, severe underarm sweating, abnormal twitch of the eyelid and a condition in which the eyes are not properly aligned.

The most common adverse reactions observed following injection of Botox into the bladder were urinary tract infection and urinary retention. Those who develop urinary retention after Botox treatment may require self-catheterization to empty the bladder.

Botox is marketed in the United States by Allergan Inc., of Irvine, Calif.

For more information:
What is Botox?: http://www.nlm.nih.gov/medlineplus/botox.html

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Jeffrey Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration




   

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