Jan 25 U.S. health regulators approved a
nonprescription version of Merck & Co Inc's Oxytrol to
treat overactive bladder in women ages 18 and older, the agency
said on Friday.
The U.S. Food and Drug Administration said the
over-the-counter version of Oxytrol would be available for women
only and that the drug remained available to men by prescription
Oxytrol for Women is a patch that contains oxybutynin, a
medicine that helps relax the bladder muscle, and is designed to
be applied to the skin every four days, the FDA said.
Oxybutynin belongs to a class of drugs known as
anticholinergics and of which Pfizer Inc's Detrol is the
market leader with annual sales of about $700 million. Oxytrol,
for which Merck does not break out sales figures, will be the
first drug in the class to be sold over-the-counter.
Merck said it expected the OTC patch to be available in the
Overactive bladder, which affects an estimated 33 million
Americans, is a condition in which the bladder squeezes too
often or without warning. Symptoms include leaking urine,
feeling a sudden and urgent need to urinate, and frequent
The FDA decided to allow the OTC version of the Merck drug
based on the results of nine studies of women that demonstrated
that consumers can understand the information on the label,
properly determine whether the product is right for them, and
use the drug appropriately, the agency said.
The FDA last week approved the popular wrinkle treatment
Botox from Allergan Inc to treat overactive bladder in
people who cannot tolerate or are not helped by drugs from the
class to which Oxytrol belongs.