Allergan Inc. is seeking to expand the medical use for its wrinkle smoother Botox, saying that injections of the drug into the bladder helped decrease symptoms of severe urinary incontinence in two studies.
Botox led to a “statistically significant” decline in incontinence among patients with overactive bladder, the Irvine, California-based company said in a statement today. Based on the results, Allergan said it has applied for approvals from the U.S. Food and Drug Administration and European Union officials.
Botox, Allergan’s best-selling product, had $1.59 billion in sales last year, about half for cosmetic uses and half for migraine treatment, incontinence and other conditions. Analysts estimate the new indication, for more-severe bladder problems, may generate about $400 million a year, Allergan Chief Executive Officer David Pyott said in a phone interview.
“I think we’re going to surprise a lot of people in the investment community,” Pyott said. “They assumed we’d be filing for this toward the end of the year.”
The company was able to enroll patients in the trials and collect data faster than expected, the CEO said. A regulatory decision from the FDA should come by early next year, he said. The studies treated patients with overactive bladders not caused by a neurological condition and who had failed to respond to standard medication, according to the company’s statement.
Allergan fell less than 1 percent to $94.05 at the close of trading in New York. The shares had gained 35 percent in the past 12 months.