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.
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’s 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.
No Drug for Females
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.
Cindi Whitehead, the president and chief operating officer of Sprout Pharmaceuticals, 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: ¨It 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. . . . ¨
Whitehead contends that the FDA’s failure thus far to approve a single treatment for female sexual dysfunction smacks of sexism, an opinion shared by other proponents of flibanserin.
Pro-Flibanserin Organizations
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’s Sexual Health believes these organizations ¨address an important unmet medical need,¨ it says it has no financial ties with either group.
Arrayed in opposition to FDA approval of flibanserin is a small but vocal minority that is alarmed by the pharmaceutical industry’s 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’s School of Medicine.
Tiefer, who also operates a limited private practice in sex therapy and psychotherapy, is the founder of New View Campaign, which was established in 2000. As outlined on its website, New View Campaign is a grassroots network ¨to challenge the distorted and oversimplified messages about sexuality that the pharmaceutical industry relies on to sell its new drugs.¨
Two-Day FDA Hearing
In October 2014, the FDA convened a two-day hearing to solicit women’s 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.
Tiefer made no secret of her disdain for the pro-flibanserin initiatives, describing Even the Score as ¨a flagrant marketing tactic disguised as a pro-woman campaign.¨ 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 ¨deceptive¨ in their claims about the inequity of treatment for male and female sexual dysfunction.
Also outspoken in its opposition to flibanserin is the American Medical Women’s 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.
Not at All Like Viagra
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.
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.
Can a Drug Increase Desire?
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, ¨It’s very distressing to hear we are committed to developing a drug, when in fact we can’t even decide what it’s for. This is not the way to do science.¨
As previously mentioned, flibanserin is a drug designed to treat HSDD, a disorder that until relatively recently was listed in ¨Diagnostic and Statistical Manual of Mental Disorders,¨ which purports to list all legitimate psychiatric disorders. HSDD was dropped from the fifth edition of DSM and replaced by ¨female sexual interest/arousal disorder,¨ which flibanserin’s proponents claim is pretty much the same thing.
Flibanserin was originally developed by German drugmaker Boehringer Ingelheim in the early 2000s. After the FDA rejected the pharmaceutical giant’s 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.
Second Petition Filed
After making some changes of its own in flibanserin’s 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.
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’s 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’s other biochemical pathways.
In late November 2014, Sprout announced that clinical testing had produced solid evidence ¨that women treated with flibanserin up to 200 milligrams at bedtime had no next-day impairment of driving ability.¨ 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.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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