Watson Pharmaceuticals Inc announced today that the U.S. Food and Drug Administration (FDA) has approved Oxytrol (oxybutynin transdermal system), the first and only transdermal therapy to treat overactive bladder (OAB), with symptoms of urge urinary incontinence, urgency and frequency. Estimated to affect more than 33 million Americans, OAB is more common than both diabetes and asthma.
"The approval of Oxytrol marks an important milestone for Watson," said Allen Chao, Chairman and Chief Executive Officer. "As a company committed to developing products that enhance the standard of care for patients, we believe Oxytrol's innovative transdermal delivery will provide OAB sufferers with a much needed treatment option. In addition, Oxytrol's approval strengthens Watson's position as a leading generic and specialty brand pharmaceutical company."
Clinical trials involving more than 1,000 subjects at over 50 U.S. centers showed that Oxytrol provides effective control of OAB symptoms over a three to four day period. Data also show that Oxytrol is well tolerated, with anticholinergic side effects, such as dry mouth and constipation, comparable to placebo. The most common adverse events occurring with Oxytrol were application site reactions.
"Side effects have long been a leading cause of treatment discontinuation among my patients suffering from overactive bladder," said Roger Dmochowski, Professor of Urology, Vanderbilt University and Oxytrol study investigator. "Oxytrol's transdermal delivery system provides physicians and patients with a convenient new treatment option to help manage the symptoms of overactive bladder with anticholinergic side effects comparable to a placebo patch. I am thrilled to have this important new treatment to offer my patients coping with this condition."