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<b>Q&A<p></p>What is this 'pink Viagra'?</b>

The Food and Drug Administration on Tuesday approved the first-ever prescription drug intended to treat women suffering from a lack of sexual desire, ending a vigorous debate over the drug's fate. Here's a look at the new drug from Sprout Pharmaceuticals:

Q: How does it work?

A: Addyi, known generically as flibanserin, acts on brain chemicals associated with mood and appetite, similar to antidepressant drugs. It's not entirely clear why the drug increases sexual desire but researchers point to its ability to increase dopamine — a brain chemical associated with appetite — while lowering serotonin, a chemical linked with feelings of satiation.

Q: Who will take this drug?

A: The FDA approved Addyi for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress. Surveys estimate that between 5.5 million to 8.6 million U.S. women have the condition, or roughly 8 to 14 percent of women ages 20 to 49. Because so many other factors affect sexual appetite, there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship problems, medical conditions and mood issues caused by other medications like sleeping aids and painkillers.

The diagnosis is not universally accepted and many psychologists argue that low sex drive should not be considered a medical condition.

Dr. Lauren Streicher, associate professor of clinical obstetrics and gynecology at Northwestern University, said that although the drug was approved for premenopausal women only, she "absolutely" would prescribe it for postmenopausal women as well.

Q: Why was the decision controversial?

A: The drug followed a long, contentious path to approval, including two previous rejections by the FDA. For years, two opposing sides have argued over the fate of the drug.

On one hand, drugmakers and some medical experts argue that women need FDA-approved medications to treat sexual disorders, which they consider serious medical problems. On the other side, consumer-safety advocates have said the drug's side effects are too risky, and there are those who question whether low libido is a medical condition.

Dr. Maureen Whelihan, a Florida gynecologist who specializes in treating women with low libido, said the FDA's action was important because it recognizes the need for drugs designed for women. "This opens a big door to research on women's' sexual dysfunction coming down the pike," she said.

Among Addyi's supporters was Amanda Parrish, a 52-year-old resident of Brentwood, Tenn., who tested the drug in an early clinical trial. She said she is eager to get back on a drug that "truly did restore my interest in sex. I wanted to get on the rooftop and shout about it."

Q: How effective is the drug?

A: Experts usually describe Addyi's effect as "modest." In company studies, women taking flibanserin reported a slight increase in sexually satisfying events each month. Their answers to separate questionnaires indicated they experienced a slight increase in desire and a slight decrease in stress. While FDA scientists describe these effects as "small," they were significant enough to meet FDA effectiveness standards. Women are advised to stop using the drug if they see no effect after eight weeks.

Q: What are the side effects?

A: About 10 percent of patients in Sprout's studies experienced the most common problems: dizziness, fatigue and nausea. Addyi should be taken at bedtime to reduce these risks, the FDA said. The drug will also bear a boxed warning that women should not drink or take certain types of other medications, because of an interaction that can cause low blood pressure and fainting.

Q: How much will it cost?

A: Sprout says women who have health insurance should pay between $30 and $75 for a month's supply of Addyi when it becomes available in October. But it is not clear if all insurance companies will pay for Addyi.

Contributing: Los Angeles Times, New York Times, Washington Post.

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