Video: FDA panel says female sex pill found wanting

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    LESTER HOLT, anchor: We have been reporting this week on the debate over a new pink pill that is supposed to revive a woman's sex drive . Today a panel of health experts made its decision about whether the pill should move a step closer to market. Dr. Nancy Snyderman joins us now. Nancy , what was the decision?

    Dr. NANCY SNYDERMAN reporting: Lester , the advisory committee blocked flibanserin from moving to FDA approval. This is the advisory panel which noted that the data from the studies presented were not convincing. And with a 70 percent incidence of side effects like nausea, anxiety and dizziness, they saw no reason to give this drug the go ahead. There were also some concerns about interactions with other drugs and some long-term safety issues. So the bottom line from the

    experts today: go back to the drawing board . Based on the risks and the benefits, this panel said that this drug is not going to be the answer.

    HOLT: So, Nancy , does today's decision challenge whether the condition itself is valid?

    SNYDERMAN: Interestingly, no. There is no issue about that. And while there was no green light today on this medication, the committee did underscore that this disorder exists and that it deserves a stronger study. This condition, known as HSDD , or hypoactive sexual desire disorder , is a legitimate and recognized medical problem. And it really goes to the fact that men and women are so different, because while a man's sex drive is more mechanical -- it depends on blood flow -- a woman's libido is more complex and involves a delicate balance of brain chemistry, too. And it's that complexity, Lester , that has caused so many delays in finding a female equivalent to the drugs that are available for men. So I think we're looking at a wait for this one.

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updated 6/18/2010 4:14:14 PM ET 2010-06-18T20:14:14

A "pink pill" to boost women's sex drive remains elusive after a decade of searching by some of the world's biggest drugmakers.

A panel of health experts on Friday rejected the latest offering submitted for federal approval to treat lack of female libido: an antidepressant drug that failed to increase sexual desire in two studies.

The Food and Drug Administration's panel of reproductive advisers voted unanimously that the benefits of the pill from Boehringer Ingelheim did not outweigh side effects, including fatigue, depression and fainting spells.

"I am convinced that women's sexual health is important and that many women suffer from sexual dysfunction, but I'm not convinced of a clinically meaningful benefit for this drug," said panelist Paula Hillard, a gynecologist from Stanford University School of Medicine.

The FDA will make its own decision on the drug in coming months, though it usually follows the advice of its panelists.

The drug flibanerin, which acts on serotonin and other brain chemicals, was originally studied as a depression therapy, but then repurposed as a libido pill after women reported unusually high levels of sexual satisfaction.

Despite a modest uptick in sexually satisfying events reported in the studies, panelists said the drug's benefits were not strong enough to warrant approval as a daily pill for women.

The attempt to trigger sexual interest through brain chemistry is the drug industry's latest approach to find a female equivalent to the blockbuster success of Pfizer's erectile dysfunction drug, Viagra.

Since that drug's 1998 launch, more than two dozen experimental therapies have been studied for so-called "female sexual dysfunction," a market worth an estimated $2 billion.

Initially, Pfizer tested Viagra on women, hoping that the drug's ability to increase blood flow to the genitals would increase libido. When that didn't work, drugmakers turned to hormones, including testosterone.

In 2004, an FDA panel rejected Procter & Gamble's testosterone patch, Intrinsa, due to unknown risks from long-term use. Two years earlier a massive government study found that hormone replacement therapy in postmenopausal women increased heart disease and breast cancer, raising concerns about the safety of all hormones.

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Will search be called to a halt?
Decision Resources analyst Alasdair Milton says that after year of disappointing results, the search for "female Viagra" may be winding down.

"In this day and age, are you really going to spend a significant amount of money developing these compounds if you're not going to get a return on your investment?" Milton asked.

But experts who have watched the drug industry's dogged pursuit of a female dysfunction drug are not convinced the end is in sight.

Dr. Leonore Tiefer, a psychiatry professor at New York University who runs a private sex therapy practice, said drug companies may target narrower groups of women to find an effective therapy, but won't give up the search anytime soon.

"I don't see that there's any incentive for the companies to stop, the market is just too big," said Tiefer.

43 percent of women experience sexual dysfunction
Drug companies frequently cite a 1999 survey in the Journal of American Medical Association that found 43 percent of U.S. women had some type of sexual dysfunction, though more rigorous, in-depth surveys have put the figure closer to 10 percent.

The field of potential competitors in the market has narrowed considerably over the years. Currently the only company with a drug in late-stage development is BioSante Pharmaceuticals Inc., a small specialty drugmaker developing a testosterone gel called LibiGel.

According to company executives, more than 1.8 million women received prescriptions for men's testosterone gel last year, suggesting a significant market. While currently marketed testosterone gels are designed to treat low hormone levels in men, doctors are free to prescribe them for alternate uses.

"That shows you doctors are willing to write prescriptions for testosterone off-label and women are willing to take it," said BioSante Chief Financial Officer Phil Donenberg.

But FDA approval of the company's LibiGel is far from certain. After lengthy discussions with the agency, the company has agreed to track over 3,000 women for more than a year to detect potential side effects.

Even if the gel turns out to be safe, Emory University Professor Kim Wallen said it's unlikely to prove effective.

"There have probably now been 50 studies on different kinds of testosterone regimens, and they all produce minimal or no effect" on sexual desire, according to Wallen. "This is a case where the pharmaceutical industry is looking in the wrong place."

Wallen still believes there could be pharmaceutical solutions to low sexual desire, possibly with other hormones like estrogen.

But he says the industry's search for a magic pill oversimplifies the problem. Sexuality is influenced by so many factors — including physical health, quality of relationships and lifestyle — that it's unrealistic to assume a drug could address millions of different cases of low libido.

"There are lots of reasons that people, both men and women, experience low sexual desire," Wallen said. "And to lump every individual into this group as potentially being amenable to drug therapy seems ill-advised."

Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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