'Female Viagra' Gets Thumbs Down From FDA Panel

Dr. Peter J. Piliero, Boehringer's director of medical affairs in the United States, has called hypoactive sexual desire disorder "a real disease."

In a multi-nation study made public last year, flibanserin appeared to increase desire and sexual satisfaction in women by several measures by modulating serotonin and other neurotransmitters.

Unlike Viagra, which is used to treat male erectile dysfunction by increasing blood flow to the genitals, this drug acts on the woman's brain to enhance mood.

Lead researchers from University of Ottawa -- whose work is underwritten by Boehringer Ingelheim Pharmaceuticals -- said the drug is effective in treating hypoactive sexual desire disorder or lack of libido.

The drug acts on the central nervous system, keeping serotonin, norepinephrine and dopamine "in balance," she told ABCNews.com.

"The pharmaceutical industry has come up with Viagra to solve a major concern that men have had since the beginning of time," June Reinisch, senior research fellow at the Kinsey Institute for Research in Sex, Gender and Reproduction told ABCNews.com when the first studies were publicized.

"But until now, nobody has seemed that concerned about resolving what women might like."

Reinisch said while the study was "interesting," there were more questions about the data -- women surveyed were 18 to 50, a wide age range, and from different countries.

There was also a very strong placebo effect among the women.

"We ladies are complicated, and this study is only looking at one thing," she said. "It may be a first step in something interesting, but to call it a female Viagra, we are getting way ahead of ourselves."

"Women are not interested in getting a hard on, they want to have desire and arousal," said Reinisch, who is also a consultant to New York's Museum of Sex.

The randomized, double-blind study on flibanserin was carried out at Canada's Women's Health Center of the Ottawa Hospital, as well as at University of Virginia, University of North Carolina Chapel Hill and Italy's University of Pavia.

Sexual Desire Improved in Study

Premenopausal women treated for 24 weeks showed significant improvements in sexual desire and functioning compared with those on a placebo.

The 1,378 study participants were required to be in a "stable, communicative, monogamous, heterosexual" relationship for at least one year.

All exhibited generalized acquired sexual dysfunction disorder or "little or no receptivity" to sexual activity. Those who had secondary problems with arousal or orgasm were excluded from the study, as well as those with psychiatric and depressive disorders or those who had taken medication that might diminish or enhance sexual function within four weeks before entering the study.

About 43 percent of women experience sexual problems, according to another Boehringer Ingelheim study that examined their prevalence in a representative sample of 30,000 U.S. women. But only 12 percent found those problems "distressing," according to Dr. Jan Shifren, principal author of the PRESIDE study.

"As almost half the U.S. adult female population reported a sexual problem, sexual concerns should not be 'medicalized,'" she told ABCNews.com. As for those who were bothered by their lack of desire, "this group of women deserves effective treatment."

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