Jan 25 U.S. health regulators approved Merck &
Co's nonprescription version of Oxytrol to treat
overactive bladder in women ages 18 and older, the agency said
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
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
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. Pfizer Inc's Detrol is the market
leader in the class with annual sales of about $700 million.
Oxytrol will be the first drug in the class to be sold over
the counter. Merck licensed exclusive rights to sell OTC Oxytrol
from Actavis Inc, the generic drugmaker formerly known
as Watson Pharmaceuticals.
Merck said it expected the OTC patch to be available in the
The FDA decided to approve 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.
Last week, the FDA approved the popular wrinkle treatment
Botox from Allergan Inc to treat overactive bladder in
people who cannot tolerate drugs from the class to which Oxytrol
belongs or are not helped by these medications.
Merck shares rose 3 cents to $43.03 on the New York Stock