Allergan Inc.'s Botox Gets FDA Approval for Overactive Bladder

Published: Jan 23, 2013

The popular Botox wrinkle treatment made by Allergan Inc has been approved to treat adults with overactive bladder who cannot tolerate or failed to be helped by other drugs for the condition, the U.S. Food and Drug Administration said on Friday. Botox injected into the bladder muscle causes the bladder to relax, increasing its storage capacity and reducing episodes of urinary incontinence, or leakage. "Clinical studies have demonstrated Botox's ability to significantly reduce the frequency of urinary incontinence," Hylton Joffe, director of the FDA's Division of Reproductive and Urologic Products, said in a statement. "Today's approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States." Botox had previously been approved for other non-cosmetic uses, such as migraine headaches, severe underarm sweating and loss of bladder control due to nerve damage. Allergan, which has yet to report full year financial results, said it expects 2012 Botox sales of $1.76 billion to $1.8 billion. Analysts have said that approval for overactive bladder could add more than $200 million a year to Botox sales. The treatment can be repeated when the effect wears off, but with a gap of at least 12 weeks between treatments, the FDA said. About 3.2 million Americans suffering from overactive bladder take oral medications from a class of drugs called anticholinergics, such as Pfizer Inc's Detrol. The Botox approval is for those who are not helped by, or cannot take, those drugs, the FDA said.

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