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The hunt for ‘pink Viagra’

It really does take more to get women in mood, drug makers find out. That’s why the search for a women’s version of the sex pill is proving tricky.Ten years ago this month, the Food and Drug Administration approved Viagra. And about five minutes after word of Pfizer’s magical med went global, the question first was asked: Where is the women’s version of Viagra?

Give us another five years, maybe less, say the most optimistic researchers and doctors. Though it’s unclear exactly how many women would ask for a prescription, no one doubts that the first company that gets to market a remedy for female sexual dysfunction (FSD), as it’s formally known, will earn a fortune.

So far, the search for “pink Viagra” is proving trickier than anticipated. It’s been one flameout after another.

There was PT-141, by Palatin Technologies of New Jersey, a drug inhaled via nasal spray and found, in preliminary tests, to produce friskiness in both men and women, leading to buzz in 2005 that people would soon be able to snort themselves into the mood. “The first real, honest-to-God, horny-making, body-shaking, equal-opportunity aphrodisiac,” panted New York magazine that year.

Nuh-uh. The FDA stopped the clinical testing, citing concerns about a side effect high blood pressure.

There was Intrinsa, a patch made by Procter & Gamble that transmitted testosterone into the bloodstream through the skin. (Testosterone, associated with sex drive, is produced naturally in women, though in far lower quantities than in men.) Also dinged by the FDA.

With men, all a medication needs to produce is arousal, a.k.a. an erection. A guy will conjure lust on his own. A woman, on the other hand, can have the physical signs of arousal and remain uninterested in sex. That’s why Viagra doesn’t work for women, even though it produces roughly the same physical effect — rushing blood to the nether regions — on them as on men.

Arousal for women does not always lead to desire: Even Pfizer had a hard time grasping that concept. The company tested 3,000 women over the course of eight years before finally abandoning hope, in 2004, that Viagra itself could be the female Viagra.

“What we know is that very little of what’s going on with women and sex is below the waist,” says Anita Clayton, a professor at the University of Virginia’s Center for Psychiatric Clinical Research and co-author of Satisfaction: Women, Sex and the Quest for Intimacy. “Almost all of it is above the neck.”

Which gets us to another complexity: If lust is “above the neck” for women, how do you measure it? To win the pink Viagra sweepstakes, the FDA wants data demonstrating an increase in the number of a woman’s “sexually satisfying events.” But that’s hard to define, and it doesn’t necessarily translate as “orgasm.”

So pink Viagra must clear a higher hurdle than Viagra ever did — it has to spark desire that also leads to satisfying events. To Clayton, it seems as if the government has set a standard that is unreasonably high.

“It’s as though the government is worried women will be turned into nymphomaniacs,” she says. “Look, the FDA blocked the morning-after pill for ages. Why? Either they’re worried we’ll be bad girls, or they don’t understand women’s sexuality.”

A number of drug companies say they can clear the FDA’s bar. In January, clinical trials began across the country for LibiGel, a testosterone gel made by BioSante. Women rub a dab of LibiGel into their upper arms once a day. (It builds up testosterone levels over the course of months.) A German company, Boehringer Ingelheim, discovered that a drug it developed for depression didn’t lift anyone’s mood but boosted desire in women. It hopes to win FDA approval in 2009.

The sooner the better, say many physicians in the field of sex medicine. They describe FSD as a silent epidemic. Studies have found that most women who are distressed by their sex lives are too embarrassed to discuss it with their doctors. Those who do speak up are often told they need a shrink.

“When I started this field in the ’70s, 90 percent of the treatment was psychological,” says Irwin Goldstein, director of sexual medicine at San Diego’s Alvarado Hospital. “It was just assumed that every couple needed therapy.”

The success of Viagra changed that. It redefined impotence as “erectile dysfunction” and revealed that a lot of men didn’t need to plumb their psyches at all; they needed greater vasodilation of the corpus cavernosum. In other words, they needed a pill.

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