Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced that its New Drug Submission for Oxytrol (oxybutynin transdermal system) has been accepted for review by the Canadian regulatory authorities. Oxytrol (oxybutynin transdermal system), the first and only transdermal therapy to treat overactive bladder (OAB), with symptoms of urge urinary incontinence, urgency and frequency, was recently approved for marketing by the U.S. Food and Drug Administration (FDA) and is now available in U.S. pharmacies.
"We are very pleased that our Oxytrol Canadian submission has been accepted for review," began Allen Chao, Ph.D., chairman and chief executive officer. "With approximately 1.5 million Canadians suffering from overactive bladder, Oxytrol will play an important role in the effective treatment of this condition. The Canadian market is another facet to our global strategy for Oxytrol and we are actively pursuing partnering opportunities for the commercialization of Oxytrol in Canada and Europe."
In addition to the Canadian submission, Oxytrol is currently under review with the European Agency for the Evaluation of Medicinal Products as part of a qualified centralized filing in the European Union. In addition, the product is in phase two clinical development in Japan with Sankyo Co., Ltd.
Oxytrol is a thin, flexible and clear patch that should be applied to the abdomen, hip or buttock twice weekly. The active ingredient in Oxytrol is oxybutynin, a medication widely accepted and prescribed in oral formulation for the past 25 years. The Oxytrol transdermal delivery system delivers 3.9 milligrams per day of oxybutynin consistently and continuously through the skin into the bloodstream, bypassing initial metabolism in the liver and the gastrointestinal tract that occurs with oral medications, providing relief of overactive bladder symptoms for up to four days. Data shows that Oxytrol is well tolerated, with a low incidence of anticholinergic side effects including dry mouth, constipation and dizziness. In clinical studies, the difference in dry mouth, constipation and dizziness between Oxytrol and placebo was not statistically significant. The most common adverse events occurring with Oxytrol were application site reactions, dry mouth, constipation, diarrhea, dysuria, and abnormal vision. Patients who have urinary retention, gastric retention, uncontrolled narrow- angle glaucoma or hypersensitivity to oxybutynin or other components of Oxytrol should not use Oxytrol.