Health
Flibanserin FDA: Female Viagra Pill will Require Additional Research

[caption id="attachment_74269" align="aligncenter" width="300"] Flibanserin FDA: Female Viagra Pill will Require Additional Research[/caption]Female Viagra Pill will Require Additional Research as per FDA
Washington D.C. - The Mayo Clinic has announced that the drug company known as Sprout Pharmaceuticals will delay launch of their much anticipated drug to treat female hypoactive sexual desire disorder (HSDD). The drug has been delayed as a result of the Food and Drug Administration (FDA). The FDA wants further assurances against potential side-effects before it is authorized for use by premenopausal women.
The drug, called flibanserin, is designed to increase the sexual appetite of woman who suffer from HSDD, which is a disorder where a person has no sexual desire even in terms of sexual fantasies. Back in the day, this was referred to as being frigid. Performing its duty to protect the public, the FDA is specifically concerned as to how flibanserin impairs driving ability especially when take in conjunction with other drugs. Thus far, 1 in 10 women in the clinical trial claimed to experience increased drowsiness or sleepiness while taking the medication.
The FDA concerns are legitimate. However, women seeking to regain a lost sexual libido or obtain one will need to wait further.
Experts say that developing drugs for female sexual dysfunction is so difficult because of how poorly we understand the root causes.
"Erectile dysfunction is a really easy thing to measure," says Emory University researcher Kim Wallen. "Motivation is a hard thing to measure and, quite honestly, we don't know enough about what creates sexual motivation to manipulate it."
And Dr. Virginia Sadock, a psychiatrist, says the idea that a single pill can restore female libido oversimplifies the problem. Even if the FDA eventually approves a drug for female sexual dysfunction, she says it will likely be used with non-drug techniques to reduce stress and improve self-image.
"A pill just doesn't take care of it," says Sadock, who teaches human sexuality at New York University's School of Medicine. "You may take a statin drug to control your cholesterol, great. But you should also exercise and you should also watch your diet."
Thus far, the FDA has not approved any drug to increase sexual desire in women despite efforts by the pharmaceutical industry to bring one to market for the past 15 years.
The FDA has twice rejected flibanserin since 2010. A key issue for the agency is that women taking the drug reported only 1.7 more satisfying sexual experiences per month than women taking placebo.
Sprout executives argue that number is statistically significant and warrants approval for their product, considering there are no other drugs approved for the condition.
"We've now got 24 drugs for men for either testosterone replacement or erectile dysfunction," says Cindy Whitehead, Sprout's chief operating officer. "Yet there are zero drugs for the most common form of sexual dysfunction in women."
On The Web:
FDA wants more studies on women's libido pill
http://www.cbsnews.com/news/fda-wants-more-flibanserin-studies-womens-libido-pill/