FDA approves 'female Viagra' with strong warning - Reuters
Aug 18, 2015 ... The first drug to treat low sexual desire in women won approval from U.S. health regulators on Tuesday, but with a warning about potentially ...
Izaya Orihara Female Version Of Viagra
Find out whats happening in the world as it unfolds. Critics say the small benefit is outweighed by the drugs risks. Another difference is that men take viagra as needed before a sexual encounter, and women take addyi once every night.
The fda had twice rejected the raleigh, north carolina-based firms drug. The news sent shares of palatin technologies, which is creating a rival drug for hsdd, up about 30 percent to 1. In clinical trials, women taking the drug experienced a 37 increase in sexual desire, according to sprout pharmaceuticals, which makes the drug.
The chief executive of sprout, cindy whitehead, co-founded the company with her husband robert whitehead in 2011 after selling another small drugmaker they had founded called slate pharmaceuticals which had received repeated warnings from the fda about its marketing tactics. Palatin in a statement late tuesday said its drug, if approved, would only be taken as needed, not on a daily basis like addyi, thereby providing women greater control and flexibility in their treatment. The condition is formally known as hypoactive sexual desire disorder, or hsdd.
In one fda warning letter, issued on march 24, 2010, the fda said slate had improperly inferred on its testopel website and in a video that the testosterone product could help patients with depression, erectile dysfunction, diabetes and hiv. In addition, the agency is requiring a boxed warning to notify patients who drink alcohol, have liver problems or those who take medications called cyp3a4 inhibitors (which interfere with the breakdown of the medication in the body) not to take addyi. The fda approved addyi despite a rocky relationship in recent years with the founders of sprout.
Addyi, whose chemical name is flibanserin, is designed for premenopausal women whose lack of sexual desire causes distress. This is more of a concern in patients who drink alcohol while taking the drug. In fact, the agency approved the drug with a risk evaluation and mitigation strategy, or rems, to ensure safety.
But those antidepressants, which raise levels of the neurotransmitter serotonin, are known to blunt libido. Addyi will come with a prominent boxed warning about side effects, including among people with liver impairment or who take addyi with alcohol or with medicines known as cyp3a4 inhibitors that include certain steroids. They will be required to warn patients of the risks of consuming alcohol while taking addyi and the importance of not doing so. A 2002 study found that up to one-third of adult women might experience hypoactive sexual desire disorder, a technical term for when women lack sexual desire or fantasy. But public citizen, a consumer watchdog group that testified against the drug earlier this year, predicted that addyi will be pulled from the market within a few years because of serious dangers to women, with little benefit to them.
'Female Viagra' gets FDA approval - CNN - CNN.com
Aug 18, 2015 ... Women who have lost their sex drive now have a "female viagra." The FDA has approved flibanserin for hypoactive sexual desire disorder in ...
Izaya Orihara Female Version Of ViagraWhy There Will Never Be a Female Viagra - The Daily Beast
Jul 26, 2014 ... Some people think the reason we don't have the equivalent of Viagra for women is that it wouldn't be profitable. In reality, nothing could be ...
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F.D.A. Approves Addyi, a Libido Pill for Women - The New York Times
Theres no doubt that sex drugs for men have been a boon for the pharmaceutical industry. Addyi will come with a prominent boxed warning about side effects, including among people with liver impairment or who take addyi with alcohol or with medicines known as cyp3a4 inhibitors that include certain steroids. It is similar to a class of other drugs known as selective serotonin reuptake inhibitors, or ssris, that include antidepressants such as prozac. The whiteheads could not be reached for comment late on tuesday about addyis approval and their earlier encounters with the fda. The drug, flibanserin, under the trade name addyi, nicknamed female viagra is shown in this undated sprout pharmaceuticals handout photo released on august 18, 2015.
The condition is formally known as hypoactive sexual desire disorder, or hsdd. The news sent shares of palatin technologies, which is creating a rival drug for hsdd, up about 30 percent to 1. Addyi works on the central nervous system, which is why its in the same category as an antidepressant. The fda had twice rejected the raleigh, north carolina-based firms drug. The rejection sparked a lobbying campaign by sprout, aided by some womens groups who accused the fda of gender bias because it had approved viagra for men - a charge the fda vigorously rejected.
Food and drug administration said the pink pill, to be sold under the brand name addyi and made by privately held sprout pharmaceuticals, will only be available through certified and specially trained health care professionals and pharmacies due to its safety issues. Pill for contraception, the national consumers league said in a statement. Another difference is that men take viagra as needed before a sexual encounter, and women take addyi once every night. Sprout acquired the drug, conducted additional studies and resubmitted the application. Slate marketed an implantable testosterone pellet for men with low levels of the male sexual hormone, called testopel. Originally developed by germanys boehringer ingelheim under its chemical name flibanserin, it was first rejected by the fda in 2010 after an advisory panel said the benefits did not outweigh the risks. Some experts say that for women, the cure for low libido is more likely to be found in their brains than in a bottle. However, experts say its a misnomer to describe it as such because it works in a distinctly different way to target the brain. . Addyi will cost about the same per month as a one month supply of viagra for men, sprout said on tuesday.Aug 18, 2015 ... The first prescription drug to enhance women's sexual drive won ... Viagra and other drugs available for men are approved to help ... but suggested it would be roughly equivalent on a monthly basis to erectile dysfunction pills.