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.For millions of women suffering from hypoactive sexual desire disorder, the most common form of female sexual dysfunction, “it’s about time” 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 drug flibanserin, sometimes called “female Viagra,” 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.
Not Like Viagra at All
It should be pointed out that while the term “female Viagra” 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’s desire for sex.
In a recent blog posting at RollCall.com, the advisory panels’ recommendation for flibanserin’s approval was characterized as “so historic, and so overdue” by Loribeth Weinstein, CEO and executive director of Jewish Women International. Of the uneven treatment of male and female medical problems, she writes that “we have watched as men in this country have been studied and treated first across the board.”
Slams Bias toward Men
Weinstein went on to say: “Whether 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.”
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 that she had spent some time talking with women who are suffering from HSDD and have been pushing for the drug’s approval.
HSDD Very Damaging
“It’s very destructive to their relationships, to their families, and their self image,” Greenberg said. “We 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.”
Young woman taking a pill and holding a glass with water,copy space for text messagePredictably, not everyone is pleased with the FDA advisory panels’ decision. One such example is filmmaker Liz Canner, producer of the feature-length documentary <i>Orgasm Inc.</i>, which looks at Big Pharma’s quest for a female answer to Viagra and the profits such a drug would bring. Canner told the Washington Post that Sprout had “deceived women into taking a drug that doesn’t work better than drinking a glass of wine or two, and could end up killing us.”
First Sent to FDA in 2010
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 “not robust enough to justify the risks.”
The positive effects referred to in the advisory panel’s 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.
How Study Was Done
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. Women given flibanserin reported an average of 2.8 sexually satisfying events during the study’s 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.
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.
German Drugmaker Bows Out
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.
HSDD can be a significant roadblock to the development of a satisfying and fulfilling love life.Based in Raleigh, North Carolina, Sprout describes itself as “wholly focused on women’s sexual health.” 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’s application for the drug.
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’s decision.
FDA Offers Guidance
In February 2014, the FDA responded to Sprout’s appeal, offering the drug company what Sprout described as “clear guidance” about further testing that might be done to improve the drug’s chances for eventual approval. Following the FDA’s 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’s biggest concerns about the drug’s side effects was the possibility that it might cause driving impairment in women who took flibanserin.
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 “the completion of the additional studies requested by FDA.”
Panels Give Thumbs Up
Finally, on June 4, 2015, a joint meeting of FDA’s 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.
In reaction to the advisory panels’ recommendation, Whitehead said that the latest decision moved Sprout “one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction.” She added that Sprout looks forward to working closely with the FDA as the agency completes its review of Sprout’s new drug application, including discussion of a Risks Evaluation and Mitigation Strategy, or REMS.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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