August 25, 2011
Botox Approved For Use In Urinary Incontinence
The US Food and Drug Administration (FDA) has given approval for Allergan, the maker of Botox, to market the drug to treat a specific kind of overactive bladder condition, Reuters is reporting.
After receiving similar approval in Europe earlier this month, US regulators are allowing Botox to be injected into the bladder to treat those who lose bladder control because of damage to the nervous system through conditions such as multiple sclerosis or spinal cord injury. Botox´ active ingredient is a toxin that blocks nerve signals.
Botox is the top-selling product for Allergan, with $1.4 billion in revenue last year, about half of which is from cosmetic uses. It is also approved to prevent migraine headaches and to treat upper limb spasticity, neck pain from cervical dystonia and certain types of eye muscle problems and spasms of the eyelids.
Sales of the drug for incontinence in people with MS and spinal cord injuries may reach $40 million in 2017, Seamus Fernandez, a Boston-based analyst at Leerink Swann & Co., said today in a note to investors and quoted by Bloomberg.
“This approval of Botox is an important milestone in Allergan´s commitment to develop and make available novel treatment options for urologists and their patients,” Scott Whitcup, Allergan´s chief scientific officer and executive vice president for research and development, said today in a statement.
A single injection into the bladder, with Botox, can increase its storage capacity, with the effect lasting for about nine months. About 60 to 80 percent of patients with multiple sclerosis or spinal cord injury experience some form of bladder problems, Allergan said, out of 350,000 such patients in the United States.
“It´s very smart for management to build out these therapeutic indications for Botox because it´s more difficult for competitors to get into these areas as opposed to the cosmetic side, where they´re probably going to see continued market share losses,” Michael Waterhouse, analyst at Morningstar, told Reuters.
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