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. Side effects were heightened in those who used the drug at the same time they were taking other medications, such as anti-fungal treatments, hormonal contraceptives, and antidepressants. Flibanserin itself was originally designed to be an antidepressant but past clinical trials found that it didn't alleviate depression.
While Flibanserin's fate rests in the hands of the FDA, a Boehringer Ingelheim spokesperson says the company is still optimistic. Also, Boehringer Ingelheim
has kicked off a widespread education campaign to make us aware that having a low sex drive is a real medical condition that affects "approximately 1 in 10 women" (a statistic disputed as overinflated by some sexual health experts). The company has hired actress Lisa Rinna to be the poster girl for low libido and funded the "Sex, Brain, Body" website that has an "educational toolkit" that urges women to please talk to their doctors if they think they have a problem.
Sources:
http://www.msnbc.msn.com
www.associated press.com
MC Ortega is the former publicist for the late Walter Payton and Coca-Cola. Ortega is a senior communications and messaging executive specializing in media relations, social media, program development and crisis communications. Also, Ortega is an avid traveler and international shopper. Ortega resides with her partner, Craig, dog, Fionne and extensive shoe collection. Ortega also enjoys jewelry design/production and flamenco dancing.