Skip to comments.US regulators to decide on 'female Viagra'
Posted on 08/18/2015 1:36:22 PM PDT by Red Badger
US regulators are expected to decide Tuesday whether to approve a drug nicknamed the "female Viagra," which would be the first pill on the market to raise women's sex drive.
In June, an advisory panel to the Food and Drug Administration urged regulators to approve the drug, flibanserin, after previously voting against it twice in years past.
This time, the experts voted 18-6 in favor of allowing the drug on the market, but with some additional risk-control measures to make sure doctors prescribe it only to patients who need it and that women are aware of the risks.
The FDA is not required to follow the advice of the panel, but it often does.
A spokeswoman for Sprout Pharmaceuticals in North Carolina told AFP that the FDA decision was expected Tuesday but was unsure what time. An FDA spokeswoman declined to comment.
If approved, flibanserin would be sold under the name "Addyi," and marketed toward pre-menopausal women.
It can have significant side effects including nausea, dizziness and sleepiness.
Safety concerns include sleepiness, fainting, low blood pressure and the potential for hormonal contraceptives and alcohol use to make side effects worse.
Experts also raised questions about the increased risk of breast cancer seen in one of two studies on lab animals.
Most commonly diagnosed disorder
The drug is a non-hormonal agent that acts on neurotransmitters in the brain, and aims to treat a condition known as hypoactive sexual desire disorder (HSDD), or loss of interest in sex, among women who have not yet entered menopause.
Rebecca Zucconi, an assistant professor of medical sciences at the Frank H. Netter School of Medicine at Quinnipiac University, said the condition is the most commonly diagnosed sexual dysfunction in women.
"Until now, physicians have been limited to recommending education, counseling, psychotherapy and, in some cases, off-label usage of testosterone and estrogen therapy as treatment options for otherwise healthy women with HSDD," Zucconi said.
"Importantly, the advisory panel gave its approval with specific concerns regarding flibanserin's safety when combined with certain medications or with alcohol.
"If approved by the FDA, flibanserin will likely be marketed and prescribed with explicit restrictions to this effect."
Two attempts at bringing the drug to market failed in 2010 and 2013, given what experts described as inconclusive advantages when compared to a placebo.
According to documents on the FDA website, women taking flibanserin reported on average 4.4 sexually satisfying encounters per month, compared to 3.7 in a placebo group and 2.7 before beginning the study.
Explore further: FDA schedules meeting on twice-rejected female libido drug
I say let her stay, even though her show sux..........................
Men will be slipping it into women’s drinks or something
Doesn’t everybody love Sophia Viagra?.............................
This is not the female Viagra. This is a clinical version of Spanish Fly.
"..I'll never get any sleep with that constant howling going on IN there"
Years ago, they did research in Great Britain on a male contraceptive and got it to the testing stage when they encountered some problems. I wish I could remember exactly what the problems were but they were minimal. Because they interfered with the pleasure aspect for the man, which were as minimal as getting a hangnail, they stopped the study and discontinued the research. Voila - today there is no male contraceptive outside of condoms.
Contrast that with the research they did on female birth control pills. Women were dying in the studies and guess what? They continued with the research and took it to market.
Yeah, women were dying in the study, but can't have the men getting hangnails you know.
Word is that one of Margaret Sanger many lovers was the inventor of the birth control pill. And word is she had enough money to help him with his research.
The reinvention of old drugs for new uses is constant. Amphetamines = Adderal & Ritalin. This one sounds like Qualudes. Same side effects too.
That may be difficult to arrange.
But Chelsea just took some and is dying to meet you: http://tse1.mm.bing.net/th?&id=HR.148331061471&w=300&h=300&c=0&pid=1.9&rs=0&p=0
I bet that gets Huma hot....
the experts voted 18-6 in favor of allowing the drug on the market
I wonder how many of those experts were men. Or were there female experts actually voting in favor of this thing?
Cars and money.
I just remembered that Henry Kissinger once said “Power” is the ultimate aphrodisiac.
A woman playing with her hair is a sign of nervousness.......................
Exactly. Can’t stop men’s pleasure - including insurance/Obamacare paying for it as if it were necessary for life.
I’ve been irritated at this for years - when are they going to help women? As if men constantly have such a “hard” time getting it going.
Maybe finally we can have something to get us in the mood again. (But I wouldn’t make it a “health” item that must be at public expense, any more than BC or Viagra....)
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