UPDATE 1-FDA OKs Merck OTC version of overactive bladder drug

Jan 25 (Reuters) - 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 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.

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 urination.

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 fall.

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 Exchange.

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FDA approves Botox for overactive bladder

WASHINGTON -- The Food and Drug Administration said Friday it has approved Allergan's Botox injection for a new use in treating patients with overactive bladder that does not respond to conventional medications.

Patients with overactive bladder experience frequent, unexpected contractions of the bladder, which causes an urgent need to urinate. About 33 million people in the U.S. have the problem, according to the FDA. The condition is typically treated with nervous system-acting drugs called anticholinergics, though they do not work for all patients.

A Botox injection treats the problem by relaxing the bladder muscles and allowing more space for urine storage.

In company trials, patients injected with Botox had 1.6 to 1.9 fewer urinary leakage problems per day than patients taking a placebo.

Botox is already approved for a half-dozen uses, most famously for removing wrinkles on the forehead, but also muscle spasms, migraine and eyelid twitching. The drug was previously approved in 2011 for urinary incontinence caused by spinal cord injury or multiple sclerosis.

Botox works by blocking the connections between nerves and muscle, temporarily paralyzing the muscle. The drug is a purified form of botulinum, one of the most toxic substances in the world.

Allergan Inc., based in Irvine, Calif., reported global sales of $1.6 billion for Botox in 2011.

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