Allergan Inc. has received United States Food and Drug Administration (FDA) approval to market the wrinkle smoother Botox as a treatment for urinary incontinence. The FDA approved the drug for people with overactive bladders who have neurologic conditions such as multiple sclerosis and spinal cord injuries, the agency said today in a statement. The medicine is injected into the bladder to increase its capacity by relaxing muscles.
Botox is traditionally used to reduce facial wrinkles and treat neurological disorders. The Irvine, California-based company generates $1.4 billion in revenue last year.
Scott Whitcup, Allergan’s chief scientific officer and executive vice president for research and development, said in a statement, “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.” Today’s approval may bode well for eventual FDA clearance of Botox for idiopathic overactive bladder, a more common condition that may boost the drug’s sales by $210 million in 2017, Fernandez said. He said he expects Allergan to seek FDA clearance for that use next year, he said.
Allergan estimates urinary incontinence from neurological complications affects nearly 340,000 individuals in the U.S., with a large percentage unresponsive to oral medications. George Benson, Deputy Director of the FDA Division of Reproductive and Urologic Products said, “Urinary incontinence associated with neurologic conditions can be difficult to manage. Botox offers another treatment option for these patients.” The FDA based its approval of Botox bladder treatment on clinical trials of 691 people suffering incontinence due to disease or injury. Those who received Botox in their bladders had a large decrease of incontinence versus those who were given a placebo. Treatment with Botox does carry side-effects such as urinary retention and urinary tract infections. Patients who experience retention may be forced to use a catheter to completely empty their bladders.
Botox, a purified form of the poison botulinum that blocks connections to nerves, won FDA approval in October as a treatment for chronic migraine headaches.