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Allergan Inc. has filed applications with U.S. and European health regulators to approve Botox injections to treat overactive bladder in adults who don’t respond well to or are intolerant of oral medications. According to two clinical trials conducted by the company, a Botox injection to the bladder significantly lowers the number of incontinence episodes not caused by neurological conditions.

In the U.S., 3.2 million people treat their overactive bladder with oral medications like Pfizer’s Detrol. However, it is believed that more than half of all patients discontinue use due to a low response rate to or intolerance of the drugs.

Botox was primarily approved to smooth facial wrinkles, but it has since been approved to treat migraines, eye muscle disorders, and upper limb spasms. In 2011, Botox generated $1.59 billion in sales, making it Allergan’s best-selling product. Adding urinary incontinence treatment to the list will create an additional source of lucrative revenue for the company. Sales are expected to reach $400 million per year.

A decision from the FDA is expected to be made early next year. In the meantime, “I think we’re going to surprise a lot of people in the investment community. They assumed we’d be filing for this toward the end of the year,” says Allergan Chief Executive Officer David Pyott.

Learn more about new drug approvals on the FDA's website.


  1. Gravatar for Joseph Nittolo

    Ms. Scott,

    I received a botex injection om March 7th and since that time have been unable to urinate on my own.

    I am now using a cather four times a day. My doctor I am fed up with. Now a scraping of the prostate may be necessary because IT MIGHT be the prostate obstructing the flow of urine.

    Prior to this procedure I had a moderate flow And just want my bladder functioning again.

    I was given a dose(200mm),as he put it 'so it worked'. No bladder flow was done prior to surgery. I've had one urinery tract infection after March 14th. In short, it has been a nightmare.

    Jose Nittolo

  2. Gravatar for Amber Scott

    @Joseph Nittolo, Thank you for the comment. You may have a claim, but you would need to speak with an attorney at length (and in private) before they would be able to give you competent advice. If you'd like to speak with us, you can call 877-696-3303 or fill out the contact form on our website, Or you can seek advice from any other lawyer. A good way to find one is to ask someone you know for a recommendation. Best of luck to you.

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