FDA Approves OTC Oxytrol Patch for Women
Merck announced that the FDA has approved Oxytrol for Women (oxybutynin transdermal system), the first over-the-counter (OTC) treatment for overactive bladder in women. Oxytrol is an antispasmodic/anticholinergic indicated to treat symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (eg, urinary urgency, frequency, leakage, urge incontinence).
The FDA approval follows an advisory committee meeting that occurred in November 2012. The prescription-to-OTC switch was based on data from several studies that demonstrated a woman's ability to correctly recognize overactive bladder symptoms, understand key safety messages on the label, judge appropriateness of the product, and proper use Oxytrol for Women in an unsupervised setting. The FDA considers this a partial switch, as Oxytrol will remain available by prescription only for the treatment of overactive bladder in men.
Each Oxytrol for Women patch delivers 3.9mg oxybutynin per day for four continuous days. Oxytrol for Women patches will be available in 4-count boxes in the fall of 2013.For more information call (800) 444-2080 or visit www.Merck.com