{"id":10762,"date":"2016-11-27T03:50:20","date_gmt":"2014-11-27T03:50:20","guid":{"rendered":"http:\/\/www.viamedic.com\/blog\/?p=2118"},"modified":"2014-11-27T03:50:20","modified_gmt":"2014-11-27T03:50:20","slug":"what-is-female-viagra-and-when-could-it-hit-the-market","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/viagra\/what-is-female-viagra-and-when-could-it-hit-the-market\/","title":{"rendered":"What Is Female Viagra and When Could It Hit the Market?"},"content":{"rendered":"
\"Many
Many women look forward to the day when drugs to treat female sexual dysfunction are available.<\/figcaption><\/figure>\n

In recent years there has been a great deal of talk about \u00a8female Viagra,\u00a8 sometimes referred to as \u00a8pink Viagra\u00a8 or the \u00a8little pink pill.\u00a8 So far no such drug is available to women, and it remains uncertain whether that will change anytime soon.<\/p>\n

The most recent hope for change comes in the form of an experimental drug called flibanserin. Developed in the early 2000s by the German pharmaceutical giant Boehringer Ingelheim, the drug is designed to help relieve the symptoms of hypoactive sexual desire disorder, or HSDD, the most common manifestation of female sexual dysfunction.<\/p>\n

Shortly after the U.S. Food and Drug Administration denied the German drugmaker\u2019s petition for approval of flibanserin in the spring of 2010, Boehringer Ingelheim decided to abandon the drug and sold its patent to North Carolina-based Sprout Pharmaceuticals<\/a>.<\/p>\n

Sprout Files Petition<\/b><\/p>\n

After conducting further testing of the drug and tweaking its formulation as studies indicated, Sprout in June 2013 filed its own petition seeking FDA approval to market flibanserin as a treatment for HSDD.<\/p>\n

Once again the FDA balked, although in issuing its late 2013 ruling on Sprout\u2019s petition the agency included some guidelines that might eventually lead to the drug\u2019s approval if Sprout opts to follow them.<\/p>\n

As convinced as ever of flibanserin\u2019s significance as a weapon in the fight against female sexual dysfunction, Sprout is soldiering on, following suggestions from the FDA\u2019s advisory panel, and hopes to resubmit its petition for the drug in early 2015.<\/p>\n

\"To
To win the FDA’s approval to market a drug, its developers must perform a series of clinical studies to demonstrate its efficacy and lack of adverse side effects.<\/figcaption><\/figure> FDA Panel\u2019s Findings<\/b><\/p>\n

In issuing their negative rulings on flibanserin petitions in both 2010 and 2013, the FDA advisory panels generally found that the benefits of the drug were somewhat outweighed by its negative effects. In issuing guidelines for a possible resubmission of the flibanserin petition, the 2013 panel\u2019s decision recommended two additional clinical studies.<\/p>\n

The first of the recommended studies would look at whether the drug impaired the ability of healthy subjects to drive after taking it. A second proposed study would explore the drug\u2019s interference — if any — with the body\u2019s other biochemical pathways.<\/p>\n

FDA\u2019s Ruling Sexist?<\/b><\/p>\n

Although Sprout has made clear its intention to continue the quest for FDA approval of flibanserin, Cindy Whitehead, its president and chief operating officer, has implied that sexism played a role in the drug regulatory agency\u2019s previous decisions on the drug.<\/p>\n

In an interview with VICE columnist Sophie Saint Thomas<\/a>, Whitehead pointed out that roughly 10 percent of women suffer from HSDD, \u00a8and to this day they don\u2019t have a single medical treatment.\u00a8 She went on to argue that sexual dysfunction is more common in women than in men and takes on a variety of different forms. \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

Also taking issue with FDA\u2019s stand on flibanserin is California-based obstetrician and gynecologist Suzanne Gilberg-Lenz, M.D., who told VICE that in her view the agency\u2019s decision is \u00a8completely sexist. Women are sexual, and not just sexual objects, but sexual in their own right. It scares many people.\u201d<\/p>\n

Puzzled by FDA\u2019s Ruling <\/b><\/p>\n

Dr. Gilberg-Lenz went on to say that she was at a loss to understand the regulatory agency\u2019s rationale for rejecting flibanserin. \u00a8There\u2019s like no major side effects that I\u2019m seeing. So what is the issue? I don\u2019t get it.\u00a8<\/p>\n

Further complicating Sprout\u2019s quest to win FDA approval for flibanserin was a change made in the fifth edition of the \u00a8Diagnostic and Statistical Manual of Mental Disorders,\u00a8 known more popularly as DSM-5. HSDD was dropped from the American Psychiatric Association\u2019s 2013 update of the manual that purports to list all psychological disorders.<\/p>\n

Although the excision of HSDD from the psychiatric manual would seem to make flibanserin a drug in search of a disease, flibanserin backers have not lost hope. In its place, the editors of DSM-5 put \u00a8female sexual interest\/arousal disorder,\u00a8 which most proponents of flibanserin believe is a condition that the drug at least partially addresses.<\/p>\n

Terms Are Misleading <\/b><\/p>\n

When used to describe flibanserin, the term \u00a8female Viagra\u00a8 is extremely misleading because of the strong differences between these two drugs and how they work. While Viagra and the rest of the so-called PDE5 inhibitors do their job by maximizing blood flow to the penis, flibanserin is a nonhormonal medication that works by making subtle changes in brain chemistry.<\/p>\n

\"Each
Each year the U.S. Food and Drug Administration must carefully weigh proposed drugs’ benefits against their adverse effects before deciding whether to approve the drug for sale to the American public.<\/figcaption><\/figure>\n

The developers of flibanserin claim that the brain \u00a8plays a central role in female sexual function and desire.\u00a8 They point to earlier studies that have found that certain neurotransmitters have a positive effect on female sexual desire while others can dampen sexual interest. Flibanserin, they say, helps to increase levels of dopamine and norepinephrine, which are associated with increased sexual desire, while lowering levels of serotonin, which is linked to a loss of libido.<\/p>\n

Not All Want Flibanserin <\/b><\/p>\n

Even as Sprout presses on with work to prepare its latest submission of flibanserin for FDA approval, the notion that female sexual dysfunction can be truly remedied by medication has come under fire from a small but vocal group opposed to the drug industry\u2019s increasing medicalization of sex.<\/p>\n

At a two-day, FDA-sponsored hearing on the concerns of women in general but focusing in particular on female sexual dysfunction, one outspoken opponent of flibanserin labeled the campaign for its approval \u00a8a flagrant marketing tactic disguised as a pro-woman campaign.\u00a8<\/p>\n

Addressing the October 2014 FDA hearing, Leonore Tiefer, a New York-based clinical psychologist and sexologist, 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

Is It the Right Goal?<\/b><\/p>\n

In an op-ed piece posted at LATimes.com in November 2014, Tiefer partnered with Dutch sexuality professor Ellen Laan to press the case against the pharmaceutical industry\u2019s focus on the goal of an elusive female Viagra that may in fact be unobtainable.<\/p>\n

Instead, they write that \u00a8if the pharmaceutical industry were truly concerned with women’s sexual well-being, companies would market drugs that are effective for women whose sexual problems are caused by physical problems or disease, such as diabetes, multiple sclerosis and spinal cord injuries. Yet efforts to test drugs for narrow markets have been curtailed on several occasions as the industry pursued its blockbuster dreams.\u00a8<\/p>\n

The op-ed also elaborates on Tiefer\u2019s earlier criticism of the campaign to get flibanserin approved by the FDA. They claim that the International Society for the Study of Women\u2019s Health is the beneficiary of large donations from the pharmaceutical industry. The society collaborated with Sprout Pharmacueticals to form two pro-flibanserin organizations, Even the Score and Women Deserve.<\/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":"

In recent years there has been a great deal of talk about \u00a8female Viagra,\u00a8 sometimes referred to as \u00a8pink Viagra\u00a8 or the \u00a8little pink pill.\u00a8 So far no such drug is available to women, and it remains uncertain whether that will change anytime soon. The most recent hope for change comes in the form of […]<\/p>\n","protected":false},"author":1,"featured_media":2113,"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-10762","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