FDA approves Botox as overactive bladder treatment

Hannah Blake

pharmaphorum

Botox, the popular wrinkle treatment by pharma company Allergen, has been approved for the expanded use to treat adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics by the US FDA.

“Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence. 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.”

Hylton V. Joffe, M.D., director of the Division of Reproductive and Urologic Products in FDA’s Center for Drug Evaluation and Research.

The FDA’s approval was based on two clinical trials of 1,105 patients with symptoms of overactive bladder. Botox, when injected into the bladder muscle, was found to make the bladder relax, which in turn increases the bladder’s storage capacity, reducing episodes of urinary incontinence.

Injecting the bladder with Botox (onabotulinumtoxinA) is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder while Botox is being injected.

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Related news:

Botox OK’d by U.S. FDA to treat overactive bladder (Reuters)

FDA Approves Botox Injection for Leaky Bladders (Medical Daily)

Reference links:

FDA press release

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