HealthDay News — The FDA has approved the use of onabotulinumtoxin A (Botox, Allergan Inc.) in adults with overactive bladder who can’t use or don’t respond to anticholinergics.
The agency previously approved the drug for use in patients with overactive bladder resulting from spinal cord injury or multiple sclerosis.
“Today’s approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States,” Hylton V. Joffe, MD, director of the Division of Reproductive and Urologic Products in FDA’s Center for Drug Evaluation and Research said in a press release.
The expanded indication is based on results from two clinical trials involving 1,105 patients with symptoms of overactive bladder who were randomly assigned to receive 20 injections of either 5 units of Botox or placebo.
After 12 weeks, patients in the Botox group had 1.6 to 1.9 times fewer episodes of urinary incontinence per day than people treated with a placebo and 1.0 to 1.7 fewer daily urinations.
Treatment with Botox can be repeated when the benefits from the previous treatment have decreased, but there should be at least 12 weeks between treatments, the FDA advised.
The most common adverse reactions include urinary tract infection, painful urination and urinary retention. Antibiotic prophylaxis to prevent UTIs should begin shortly before starting Botox therapy and continue for several days afterward, the agency said. Patients with active urinary tract infections should not start Botox. Patients who develop urinary retention may need to use a catheter until the situation resolves.