Irvine-based drug maker Allergan Inc. said the Food and Drug Administration approved its flagship Botox for treating a form of overactive bladder.
The FDA said that Botox can be injected into the bladder to treat patients who lose bladder control because of nervous system damage resulting from conditions such as multiple sclerosis or spinal cord injuries. Overactive bladder causes frequent urination, the urgent need to urinate and an inability to control urination.
Allergan just got a similar approval from European regulators earlier this month.
One injection of Botox can relax the bladder and increase its storage capacity, an effect that lasts for 10 months, Allergan said.
The drug maker will try to gain approval for a broader population of patients with overactive bladder, said Allergan Chief Executive David Pyott.
Analysts project that Botox could gain up to $500 million in annual sales if regulators approve wider use, Pyott said.
Allergan expects annual sales of about $5.3 billion this year. It gets about $1.5 billion from Botox, and about half of that comes from its cosmetic use for smoothing wrinkles.
In late 2010, Allergan got much-coveted approval by the Food and Drug Administration to use flagship Botox for treating chronic migraine headaches. Analysts have said that Botox for migraine could add as much as $500 million in annual sales for the drug.
Allergan also has ongoing collaboration efforts with other drug makers, including a development deal with Irvine-based Spectrum Pharmaceuticals Inc. on apaziquone, a potential drug for bladder cancer.
