Video: Female sex pill arouses doubt at FDA

  1. Transcript of: Female sex pill arouses doubt at FDA

    LESTER HOLT, anchor: For about 10 years, ever since the FDA approved Viagra for men, drug companies have been searching for a similar holy grail for women . So far, no luck. And critics say trying to treat women 's sexuality with a pill will never work. Still, that hasn't stopped drug companies from trying. And this week a little pink pill is the center of attention. Here's our chief medical editor, Dr. Nancy Snyderman .

    Dr. NANCY SNYDERMAN reporting: It's a multibillion-dollar industry...

    SNYDERMAN: ...but so far it's only been a man's game. The little blue pill changed intimacy for millions of men, and now the little pink pill hopes to shift the attention to women . The medical problem HSDD , or hypoactive sexual desire disorder , is one type of sexual dysfunction in women , and may affect up to 40 percent of the population.

    Dr. PETER PILIERO (Boehringer Ingelheim): We have been committed as a company to doing research in this area because there is an unmet medical need for women who are suffering from this condition.

    SNYDERMAN: At a hearing this Friday, an FDA advisory panel will be asked to recommend the drug flibanserin for agency approval. But in a study of 5,000 women questions are being raised about how well flibanserin really works, and whether it's safe enough for most women . The FDA today said that the drug's overall response rate in test subjects was not particularly compelling. Side effects include depression, fainting and dizziness. For men, sexual dysfunction pills work by increasing blood flow.

    Dr. PILIERO: Women 's sexual response is different than men's.

    SNYDERMAN: Flibanserin is related to the family of antidepressants. It zeroes in on serotonin, which affects mood and sexual desire . But gynecologist Dr. Bernadette Russell is skeptical, pointing out women 's sexuality is very different than men's.

    Dr. BERNADETTE RUSSELL: Solving the problem of female sexual dysfunction is unlikely, in my opinion, to be addressed by a single pill.

    SNYDERMAN: This medication is intended for premenopausal women . But one of the big concerns is that flibanserin was not tested on women who have been taking antidepressants or oral contraceptives. And that means that in the meantime all eyes are on the FDA meeting on Friday as to whether women will

    continue to wait. Lester: Nancy , I know there's another FDA adviser committee meeting tomorrow...

    HOLT: Mm-hmm.

    SNYDERMAN: ...on another controversial drug. It's a new contraceptive. What can you tell us about that?

    HOLT: This is coming from a French drug company , and this company is also looking for approval for a pill that, frankly, works longer after the morning after. The drug is called -- being dubbed Ella and would be sold as a contraceptive, one that could prevent pregnancy for as many as five days after unprotected sex. But it is a close chemical to the cousin -- the abortion pill , you might remember, RU-486 , meaning that it might induce abortion by making the womb inhospitable for an embryo. It has been approved in Europe , that was last year, and it is available as an emergency contraceptive in at least 22 other countries, so expect this one to be on a lot of people's radar screen, too, Lester .

    SNYDERMAN:

updated 6/16/2010 2:35:22 PM ET 2010-06-16T18:35:22

A pink pill designed to boost sex drive in women — the latest attempt by the drug industry to find a female equivalent to Viagra — fell short in two studies, federal health regulators said Wednesday.

The Food and Drug Administration is considering Boehringer Ingelheim's drug flibanserin for premenopausal women who report a lack of sexual desire, a market that drugmakers have been targeting for more than a decade since the blockbuster success of Viagra in men.

The search for so-called "female Viagra," has proved elusive though, with many drugs abandoned after showing lackluster results.

On Friday the FDA will ask a panel of experts to weigh in on the safety and effectiveness of Boehringer's drug. The agency is not required to follow the group's advice, though it often does.

In its review posted online, the FDA said two Boehringer studies failed to show a significant increase in sexual desire, as recorded by women in a daily journal. Women taking the drug reported slightly more sexually satisfying experiences, but FDA said that was not the primary measure of the study.

"The division wanted to see that an effect of treatment is an overall increase in sexual desire regardless of whether a sexual event occurred or not," states the FDA review.

The FDA also noted increased side effects like depression, fainting and dizziness seen among women taking the pink pill.

The drug, which is related to the antidepressant family, affects serotonin and several other brain chemicals, though it's not clear how that increases sex drive.

"We don't know specifically what the exact mechanism of action is but we believe it acts on brain chemicals that have a role in human sexual response," said Dr. Peter Piliero, executive director for Boehringer's U.S. medical affairs.

Since the launch of Viagra in 1998, more than two dozen experimental therapies have been studied for so-called "female sexual dysfunction," a market which some analysts estimate at $2 billion.

Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York, says arousal in women is so complicated that it may be unrealistic to expect a pill to completely address sexual problems.

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"It's a fairly complicated area, unlike in men's sexual dysfunction where there's a major mechanical concern," said Kavaler. "In women there's no mechanical concern, so if she's not having a successful sex life, where is the problem?"

Pharmaceutical approaches to boosting female libido have evolved over time. Initially, most treatments aimed to increase blood flow to the genitals, similar to Viagra. A second wave of would-be blockbusters focused on boosting hormones, including testosterone, which is linked to sexual interest. Flibanserin is the first drug to approach the problem through brain chemistry.

The FDA has approved an unusual handheld vacuum device that increases blood flow to the clitoris to increase sexual arousal. But all drug therapies have fallen short so far.

In 2004, Pfizer halted its study of Viagra in women due to inconclusive results. Later that year an FDA panel rejected Procter & Gamble's testosterone patch Intrinsa, due to potential risks of heart disease and cancer. Smaller companies are currently developing creams and nasal sprays to increase female libido.

BioSante Pharmaceuticals Inc. expects to submit its testosterone gel LibiGel for FDA approval next year.

Medical surveys have estimated more than 40 percent of women suffer from some form of sexual dysfunction; Boehringer estimates as many as one in 10 women could be helped by its drug.

Boehringer tried to zero in on the chemical aspect of sexual dysfunction by only testing its drug on premenopausal women who were in stable relationships and not taking other medications. Despite wanting to have a sexual relationship, the women enrolled in company studies reported a persistent lack of desire that caused them "distress or interpersonal difficulty."

Leonore Tiefer, a psychiatry professor at New York University who runs a private sex therapy practice, believes drugmakers have oversimplified female sexuality. She says in most cases lack of sex drive has more to do with the quality of one's relationship and lifestyle than brain chemicals.

During the public comment period at Friday's meeting, Tiefer will ask the FDA to reject flibanserin, arguing it offers meager benefits for women with unknown long-term risks.

The modest results reported by Boehringer have also cooled Wall Street's expectations for the drug.

Decision Resources analyst Alasdair Milton said he expects flibanserin sales to peak at $300 million after six or more years on the market. By comparison, male sexual dysfunction drugs including Viagra, Cialis and others posted combined sales of $4.4 billion last year, according to health care data firm IMS Health.

Privately-held Boehringer Ingelheim posted sales of $12 billion last year. The Ingelheim, Germany -based company makes a range of prescription drugs for heart disease, HIV and other diseases.

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

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