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.