{"id":2196,"date":"2015-01-19T05:23:02","date_gmt":"2015-01-19T05:23:02","guid":{"rendered":"http:\/\/www.viamedic.com\/blog\/?p=2196"},"modified":"2015-01-19T05:23:02","modified_gmt":"2015-01-19T05:23:02","slug":"the-case-for-and-against-pink-viagra","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/viagra\/the-case-for-and-against-pink-viagra\/","title":{"rendered":"The Case For and Against Pink Viagra"},"content":{"rendered":"
\"Although
Although flibanserin is sometimes referred to as pink Viagra, the two medications have very little in common.<\/figcaption><\/figure>\n

Sometime later this year, the U.S. Food and Drug Administration is expected to make a final decision in the case of a proposed drug that some have likened to a female or pink Viagra. In the meantime, a heated debate continues about the issue of sexual equality in the development and marketing of medications designed to treat various forms of sexual dysfunction.<\/p>\n

The drug in question, flibanserin, is designed to treat hypoactive sexual desire disorder, or HSDD, the most common form of female sexual dysfunction. According to Psychology Today, HSDD is defined as a persistent or recurring lack of sexual desire and an absence of sexual fantasies. Flibanserin\u2019s supporters argue that it would represent at least a token response by the pharmaceutical industry and the government to the issue of female sexual dysfunction.<\/p>\n

No Drug for Females <\/b><\/p>\n

Advocates of flibanserin contend that while several drugs designed to treat male sexual dysfunction have been on the market for more than a decade, the FDA has yet to approve a single drug for the treatment of female sexual dysfunction.<\/p>\n

Cindi Whitehead, the president and chief operating officer of Sprout Pharmaceuticals<\/a>, which holds the patent on flibanserin, points out that sexual dysfunction is more common in women than in men and takes a variety of forms. In an interview with a columnist for VICE.com, Whitehead said: \u00a8It can be arousal, it can be orgasm, or it can be pain disorders. By far the most common sexual dysfunction in women is low sexual desire. . . . \u00a8<\/p>\n

Whitehead contends that the FDA\u2019s failure thus far to approve a single treatment for female sexual dysfunction smacks of sexism, an opinion shared by other proponents of flibanserin.<\/p>\n

Pro-Flibanserin Organizations<\/b><\/p>\n

Helping to gather support for FDA approval of flibanserin are two organizations, Even the Score and Women Deserve. These lobbying organizations are actively pushing for the approval of flibanserin as well as initiatives to find still other treatments for female sexual dysfunction. Although the International Society for the Study of Women\u2019s Sexual Health believes these organizations \u00a8address an important unmet medical need,\u00a8 it says it has no financial ties with either group.<\/p>\n

Arrayed in opposition to FDA approval of flibanserin is a small but vocal minority that is alarmed by the pharmaceutical industry\u2019s increasing medicalization of sex — not just for women but for men as well. One of the more outspoken leaders of that movement is Leonore Tiefer, Ph.D., associate clinical professor of psychiatry at New York University\u2019s School of Medicine.<\/p>\n

\"Opponents
Opponents of flibanserin question whether any medication can effectively increase sexual desire.<\/figcaption><\/figure>\n

Tiefer, who also operates a limited private practice in sex therapy and psychotherapy, is the founder of New View Campaign<\/a>, which was established in 2000. As outlined on its website, New View Campaign is a grassroots network \u00a8to challenge the distorted and oversimplified messages about sexuality that the pharmaceutical industry relies on to sell its new drugs.\u00a8<\/p>\n

Two-Day FDA Hearing <\/b><\/p>\n

In October 2014, the FDA convened a two-day hearing to solicit women\u2019s concerns in general. The vast majority of the testimony heard, however, focused on the issue of female sexual dysfunction. Representatives from both sides spoke about their concerns.<\/p>\n

Tiefer made no secret of her disdain for the pro-flibanserin initiatives, describing Even the Score as \u00a8a flagrant marketing tactic disguised as a pro-woman campaign.\u00a8 In a Los Angeles Times op-ed she co-wrote with Dutch sexologist Ellen Laan, both Even the Score and Women Deserve are characterized as \u00a8deceptive\u00a8 in their claims about the inequity of treatment for male and female sexual dysfunction.<\/p>\n

Also outspoken in its opposition to flibanserin is the American Medical Women\u2019s Association, which opposed the drug previously in two earlier petitions to the FDA. AMWA opposes the drug on the grounds that its side effects outweigh minimal effectiveness and also because there is no long-term safety data for flibanserin.<\/p>\n

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

Although flibanserin is sometimes casually referred to as female or pink Viagra, it is a very different sort of drug. While Viagra and the other popular impotence medications promote strong blood flow to facilitate the erectile process, flibanserin is a nonhormonal drug that makes subtle changes in brain chemistry to increase sexual desire.<\/p>\n

Flibanserin works on the premise that certain neurotransmitters in the brain tend to dampen sexual interest while others are more likely to promote sexual desire. Flibanserin lowers brain levels of serotonin, which is associated with a loss of libido, while increasing levels of dopamine and norepinephrine, which are believed to have a positive influence on sexual desire.<\/p>\n

Can a Drug Increase Desire?<\/b><\/p>\n

Tiefer and others opposed to flibanserin question whether medication holds the key to low sexual desire among some women. In her testimony at the FDA hearing, Tiefer said, \u00a8It\u2019s very distressing to hear we are committed to developing a drug, when in fact we can\u2019t even decide what it\u2019s for. This is not the way to do science.\u00a8<\/p>\n

\"Flibanserin's
Flibanserin’s manufacturer and supporters believe it can successfully treat hypoactive sexual desire disorder, the most common manifestation of female sexual dysfunction.<\/figcaption><\/figure>\n

As previously mentioned, flibanserin is a drug designed to treat HSDD, a disorder that until relatively recently was listed in \u00a8Diagnostic and Statistical Manual of Mental Disorders,\u00a8 which purports to list all legitimate psychiatric disorders. HSDD was dropped from the fifth edition of DSM and replaced by \u00a8female sexual interest\/arousal disorder,\u00a8 which flibanserin\u2019s proponents claim is pretty much the same thing.<\/p>\n

Flibanserin was originally developed by German drugmaker Boehringer Ingelheim in the early 2000s. After the FDA rejected the pharmaceutical giant\u2019s petition for approval to market flibanserin in the spring of 2010, Boehringer Ingelheim sold its patent for the drug to Sprout, which is headquartered in Raleigh, North Carolina.<\/p>\n

Second Petition Filed<\/b><\/p>\n

After making some changes of its own in flibanserin\u2019s formulation, Sprout in June 2013 filed another petition with the FDA seeking a green light to market the drug as a treatment for HSDD. Once again, the FDA turned thumbs down on flibanserin but did offer some guidance to Sprout about steps it might take to eventually win approval for the drug.<\/p>\n

Although disappointed that flibanserin had once again been rejected, Sprout took heart from the guidelines that FDA outlined as a possible pathway to eventual approval. Essentially, the FDA wanted more information about two specific areas of the drug\u2019s effects. Specifically, the regulatory agency wanted clinical testing to show whether the drug might impair the driving ability of someone who had taken it as well as a study to see if flibanserin interfered in any way with the body\u2019s other biochemical pathways.<\/p>\n

In late November 2014, Sprout announced that clinical testing had produced solid evidence \u00a8that women treated with flibanserin up to 200 milligrams at bedtime had no next-day impairment of driving ability.\u00a8 The company announced that it hoped to resubmit its petition for flibanserin approval sometime during the first quarter of 2015. In addition to the driving study, the company previously completed a clinical study into possible drug interactions, which also will be submitted to the FDA.<\/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

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Sometime later this year, the U.S. Food and Drug Administration is expected to make a final decision in the case of a proposed drug that some have likened to a female or pink Viagra. In the meantime, a heated debate continues about the issue of sexual equality in the development and marketing of medications designed […]<\/p>\n","protected":false},"author":1,"featured_media":2195,"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-2196","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