{"id":2512,"date":"2015-08-10T01:59:25","date_gmt":"2015-08-10T01:59:25","guid":{"rendered":"http:\/\/www.viamedic.com\/blog\/?p=2512"},"modified":"2015-08-10T01:59:25","modified_gmt":"2015-08-10T01:59:25","slug":"why-female-viagra-is-so-important","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/viagra\/why-female-viagra-is-so-important\/","title":{"rendered":"Why Female Viagra Is So Important"},"content":{"rendered":"
\"Most
Most — but not all — American women were pleased with the FDA advisory panels’ approval of a drug to counteract hypoactive sexual desire disorder in women.<\/figcaption><\/figure>\n

For millions of women suffering from hypoactive sexual desire disorder, the most common form of female sexual dysfunction, \u201cit\u2019s about time\u201d is the collective reaction to the latest development in the long and tortuous saga of a drug to combat HSDD.<\/p>\n

If the Food and Drug Administration follows the recommendation of its advisory panels, the drug flibanserin, sometimes called \u201cfemale Viagra,\u201d may soon be available to women suffering from HSDD. If so, it will be the first such drug for women, who have long decried what they see as sexism in the absence of any medication for female sexual dysfunction even as multiple drugs are made available for men.<\/p>\n

Not Like Viagra at All<\/b><\/p>\n

It should be pointed out that while the term \u201cfemale Viagra\u201d has been widely used to describe flibanserin, the drug in question is quite unlike Viagra in the way that it does its job. While Viagra optimizes blood flow to the penis to overcome male erection problems, flibanserin works on brain chemistry to increase women\u2019s desire for sex.<\/p>\n

In a recent blog posting at RollCall.com, the advisory panels\u2019 recommendation for flibanserin\u2019s approval was characterized as \u201cso historic, and so overdue\u201d by Loribeth Weinstein, CEO and executive director of Jewish Women International. Of the uneven treatment of male and female medical problems, she writes that \u201cwe have watched as men in this country have been studied and treated first across the board.\u201d<\/p>\n

Slams Bias toward Men <\/b><\/p>\n

Weinstein went on to say: \u201cWhether it is heart disease, sexual dysfunction, or one of a long list of other medical conditions, until recently all the scientific research has been done on men, and medical treatments have won approval and been marketed first to men. Sexual dysfunction is certainly no exception.\u201d<\/p>\n

Also pleased with the latest step forward for flibanserin, which will be marketed as Addyi if FDA gives the final go-ahead, is Sally Greenberg, executive director of the National Consumers League. She told the Washington Post <\/a>that she had spent some time talking with women who are suffering from HSDD and have been pushing for the drug\u2019s approval.<\/p>\n

HSDD Very Damaging <\/b><\/p>\n

\u201cIt\u2019s very destructive to their relationships, to their families, and their self image,\u201d Greenberg said. \u201cWe know this is a problem with their brain chemistry. Just like depression. And, just like depression, their brain chemistry can be adjusted. We can treat it. And we should treat it.\u201d<\/p>\n

\"Young
Young woman taking a pill and holding a glass with water,copy space for text message<\/figcaption><\/figure>\n

Predictably, not everyone is pleased with the FDA advisory panels\u2019 decision. One such example is filmmaker Liz Canner, producer of the feature-length documentary <i>Orgasm Inc.<\/i>, which looks at Big Pharma\u2019s quest for a female answer to Viagra and the profits such a drug would bring. Canner told the Washington Post that Sprout had \u201cdeceived women into taking a drug that doesn’t work better than drinking a glass of wine or two, and could end up killing us.\u201d<\/p>\n

First Sent to FDA in 2010 <\/b><\/p>\n

Developed by German pharmaceutical giant Boehringer Ingelheim, flibanserin was first submitted to the FDA for approval by that company in the spring of 2010. In June 2010, members of an FDA advisory panel unanimously recommended against FDA approval of the drug, saying that its positive effects were \u201cnot robust enough to justify the risks.\u201d<\/p>\n

The positive effects referred to in the advisory panel\u2019s rejection of flibanserin were documented by the German drugmaker in a study of 1,378 premenopausal women who were given the drug or a placebo over a 24-week period. Women in the study group had been in monogamous relationships for an average of 10 years.<\/p>\n

How Study Was Done<\/b><\/p>\n

Study participants were randomly designated to take either a placebo or 100-milligram dose of flibanserin daily. All were required to daily record whether they had had sex and, if so, whether it was satisfying. \u00a0Women given flibanserin reported an average of 2.8 sexually satisfying events during the study\u2019s four-week baseline period. These same women reported an average of 4.5 such events during the final four weeks of the 24-week study. This represented an increase of more than 50 percent.<\/p>\n

The control group, given placebo, reported an average of 2.7 sexually satisfying events during the first four-week period, a figure that had increased to 3.7 per week during the final four-week period. Side effects of the drug among both groups included dizziness, fatigue, and nausea. The advisory panel was not persuaded that putting up with those side effects was worth the 0.8 additional sexually satisfying event reported by women taking flibanserin.<\/p>\n

German Drugmaker Bows Out<\/b><\/p>\n

Thus rebuffed by the FDA, Boehringer Ingelheim in October 2010 announced that it was discontinuing its efforts to develop and promote the drug. The following year, a fledgling drug company dubbed Sprout Pharmaceuticals Inc. purchased the rights to the flibanserin patent and announced its intentions to continue the fight to win approval for the drug.<\/p>\n

\"HSDD
HSDD can be a significant roadblock to the development of a satisfying and fulfilling love life.<\/figcaption><\/figure>\n

Based in Raleigh, North Carolina, Sprout describes itself as \u201cwholly focused on women\u2019s sexual health.\u201d Once it had acquired the rights to flibanserin, Sprout set about doing additional testing along the lines suggested by the FDA advisory panel in its denial of Boehringer Ingelheim\u2019s application for the drug.<\/p>\n

In June 2013, shortly after the completion of multiple studies showing beneficial effects from the drug, Sprout once again submitted an application to the FDA requesting approval to market flibanserin. A few months later, an FDA advisory panel once again turned thumbs down on the drug. Not ready to give up on flibanserin, Sprout in December 2013 filed an appeal of the advisory panel\u2019s decision.<\/p>\n

FDA Offers Guidance <\/b><\/p>\n

In February 2014, the FDA responded to Sprout\u2019s appeal, offering the drug company what Sprout described as \u201cclear guidance\u201d about further testing that might be done to improve the drug\u2019s chances for eventual approval. Following the FDA\u2019s suggestions, Sprout undertook another round of rigorous testing in an effort to remove some of the questions about possible side effects. One of the FDA advisory panel\u2019s biggest concerns about the drug\u2019s side effects was the possibility that it might cause driving impairment in women who took flibanserin.<\/p>\n

In February 2015, Sprout once again resubmitted its petition for FDA approval of the drug. At that time, Sprout CEO Cindy Whitehead said that the resubmission marked \u201cthe completion of the additional studies requested by FDA.\u201d<\/p>\n

Panels Give Thumbs Up<\/b><\/p>\n

Finally, on June 4, 2015, a joint meeting of FDA\u2019s Bone, Reproductive, and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended approval of the drug, but only if certain risk management options other than labeling were implemented.<\/p>\n

In reaction to the advisory panels\u2019 recommendation, Whitehead said that the latest decision moved Sprout \u201cone step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction.\u201d She added that Sprout looks forward to working closely with the FDA as the agency completes its review of Sprout\u2019s new drug application, including discussion of a Risks Evaluation and Mitigation Strategy, or REMS.<\/p>\n

Don Amerman<\/i><\/a> is a freelance author who writes extensively about a wide array of nutrition and health-related topics. <\/i><\/p>\n","protected":false},"excerpt":{"rendered":"

For millions of women suffering from hypoactive sexual desire disorder, the most common form of female sexual dysfunction, \u201cit\u2019s about time\u201d is the collective reaction to the latest development in the long and tortuous saga of a drug to combat HSDD. If the Food and Drug Administration follows the recommendation of its advisory panels, the […]<\/p>\n","protected":false},"author":1,"featured_media":2509,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_autoblog_aioseo_focus_keyphrase":"","_autoblog_aioseo_title":"","_autoblog_aioseo_description":"","footnotes":""},"categories":[17],"tags":[],"class_list":["post-2512","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-viagra"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t