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Pink Viagra Leaves FDA Unsatisfied

By HERWriter
 
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Flibanserin, a new drug designed to boost sexual desire in premenopausal women has hit a potentially serious snag. The pink pill (anticipated to become the first "female Viagra") did not boost women's desire any more than a placebo in two clinical trials.

The drug is related to the antidepressant family and affects serotonin and a number of other brain chemicals. Drug maker Boehringer Ingelheim is seeking Food an Drug Administration (FDA) approval of the drug.

On June 18, an FDA committee composed of reproductive health experts will meet to discuss the safety and effectiveness of Flibanserin for use in women with hypoactive sexual desire disorder (low sexual desire-HSDD). According to some estimates, nearly 40 percent of women in the United States are affected with HSDD. Currently, there is no medication approved to treat HSDD in women.

According to a report posted on the FDA website, when compared with a placebo, the response rate (clinical trial of 5,000 women) of Flibanserin was "not compelling" and the drug yielded only slight improvements for treating HSDD. 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 search for so-called "female Viagra" has proved elusive with many drugs abandoned after showing lackluster results. 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.

Flibanserin is the first drug to approach the problem through brain chemistry. Initially, most HSDD treatments aimed to increase blood flow to the genitals, similar to Viagra. A second wave of experimental drugs focused on boosting hormones, including testosterone, which is linked to sexual interest.

Another troubling issue is Flibanserin has side effects that may outweigh its benefits. About 15 percent of Flibanserin users in the experimental trial stopped taking the drug because of bad reactions like dizziness, nausea, anxiety and insomnia, compared to seven percent of the placebo users.

Add a Comment3 Comments

I don't think the fda is not approving it because it's a drug for women. Too many people would benefit - esp the men! I think they just don't understand a woman's sexuality to the same degree that they do a mans sexuality. I have read about studies they have done and all the findings are all over the place. In one, they would make a poster of a sexual situation and track the eye movement of men and women. The men pretty consistently looked first at the woman's face to determine if she was happy about what was going on. The women did not have as consistent of a pattern. But there is so much money to made made when they do figure this out, that you know someone is going to be able to do it.

July 19, 2010 - 9:05pm
EmpowHER Guest
Anonymous

i think this strategy would be really work.

July 10, 2010 - 5:20am

its just not going to happen for us. the FDA will never approve a drug for women. based on the fact that we are women. there are many reasons i believe this is true. we are still in the dark ages ladies whether we believe it or not. its very sad because if women were satisfied, we would want sex more often and many men would reap the benefits and probably wouldnt need viagra as much! men think about pleasing themselves. many researchers are male. there you go, only my opinion. im 50 and probably will never get help for my problem and i have tried and tried.

June 25, 2010 - 7:59am
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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