October 10, 2002
Oxytrol Patch Approved by FDA for Overactive Bladder
CORONA, Calif., Feb 26, 2003---Watson Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has approved Oxytrol (oxybutynin transdermal) for treatment of overactive bladder (OAB). The patch is the first transdermal system for treatment of this condition, which is estimated to affect more than 33 million Americans.
Although the active ingredient (oxybutynin) has been available in pill form for years, side effects---especially dry mouth and constipation---have been a limiting problem for many patients. With the patch, these side effects are less frequent and less severe than with oral forms of the drug. In the clinical trials leading to FDA approval, side effects in the Oxytrol group were about the same as in the placebo group. Thus, transdermal delivery of the drug appears to offer an advantage over the oral route of administration in some patients. Head-to-head comparisons of the two forms of delivery are not currently available.
Oxytrol Package Insert
Overactive Bladder Resources
Watson press release announcing FDA approval of Oxytrol patch
What is Overactive Bladder (OAB)?
Key Phase III trial data on Oxtytrol (R.Dmochowski, M.D., et al, Journal of Urology, August, 2002)
review of Oxytrol