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A committee of advisers to the U.S. Food and Drug Administration (FDA) are meeting to consider whether the FDA should approve the first drug that aims to boost a woman's libido:
The FDA has twice before rejected the drug, called flibanserin, after previous advisory panels concluded there were questions about its safety and insufficient evidence that the drug was effective for women with low sex drives. Sprout Pharmaceuticals, which makes flibanserin, has submitted more research that the company hopes will finally convince the advisers and the agency the drug is ready for the market. The company's evidence includes a study it says shows women can safely drive after using the medication. One concern about the drug is that it can leave women drowsy the day after taking it, increasing the risks for accidents. "The review of flibanserin... represents a critical milestone for the millions of American women and couples who live with the distress of this life-impacting condition without a single approved medical treatment today," Cindy Whitehead, Sprout's CEO, said in a statement before the hearing began.
Flibanserin, which the company plans to sell under the brand name Addyi if approved, shifts the balance of three key brain chemicals, increasing dopamine and norepinephrine and decreasing serotonin.
The drug has long been the focus of an intense debate. The company and some advocacy groups, including the National Organization for Women and Even the Score, have suggested that the FDA is being sexist by holding the drug to a higher standard than drugs, such as Viagra and Cialis, for male sexual problems. The FDA denies those charges. In documents posted online in advance of the hearing, Hylton Joffe, director of the FDA's Division of Bone, Reproductive and Urologic Products, said that such claims "are misleading and inaccurate." "The FDA rejects claims of gender bias," Joffe wrote. "The FDA's regulatory decision for each product is based on an assessment of whether the benefits outweigh the risks, and does not take gender into consideration." Many women's health advocates agree with the agency's caution and remain opposed to the drug despite the company's new research.
Original Submission
(Score: 1, Informative) by Ethanol-fueled on Friday June 05 2015, @11:42PM
This article is making my angry, because those commenting are uninformed of such things.
Disclaimer - I have had in the past a prescription for an erectile-dysfunction drug, which was revoked when the doctor suspected that I had been using it recreationally.
I gave up on looking for the article, but when I was still in high school Cosmopolitan magazine actually printed an article from a woman who (anonymously, of course) tried Viaagrah* and experienced the female analog of the drug's effects on men. One specific phrase I remembered from that article was something like, " My nipples and clit were both on fire... "
In a good way, of course. Fast-forward to a few years ago when I got my prescription. I explained to a female partner what I had read in that article, and that it was supposed to affect women similarly, so I gave her a dose and we tried it. I had observed that her nipples were both turgid and erect to the point of very noticeable color change, and that her insides were at once what would have taken me a good half-hour of effort to achieve. The Cosmopolitan interview may be buried, but it was factually accurate.
In short, if any of you need a "Viaagrah* for Women," you men just give her some of yours and you women just ask for some of his. I assure you, there is no need for an additional drug here.
* name changed to bypass the spam filter
(Score: 0) by Anonymous Coward on Saturday June 06 2015, @03:12PM
This is correct. Those little blue pills work just as well for women as they do men. There's no need as a "Viagera for women" because viagera already works just fine for women.