• by Thom Forbes  @tforbes, June 5, 2015

A hearing room packed with supporters of the female libido pill flibanserin burst into applause yesterday when an advisory panel voted 18 to 6 to recommend its approval to the Food and Drug Administration. The FDA has twice before rejected the daily treatment over concerns about the risks of side effects such as low blood pressure, dizziness, nausea and sleepiness measured against what some see as minimal results in clinical trials but the company claims are “significant” improvements in desire.

The decision to support Sprout Pharmaceuticals’ branded Addyi as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women by the joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee hinges on the manufacturer, Sprout Pharmaceuticals, implementing risk management options beyond labeling.

“With today's decision, we are one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction,” said Cindy Whitehead, CEO of Sprout Pharmaceuticals in a statement. Whitehead and her husband, Robert — both veterans of the pharmaceutical industry — purchased the rights for flibanserin from developer Boehringer Ingelheim and launched Sprout in Raleigh, N.C., in 2011 after the earlier FDA defeats.

“Interestingly, flibanserin was originally an anti-depressant before BI tried to reposition it for FSD,” Alex Philippidis wrote in a 2012 survey of developing female sexual dysfunction (FSD) drugs for Genetic Engineering & Biotechnology News.

When Whitehead was asked why it looks like the drug will be approved on this third attempt, she said “it was a change in the conversation ‘really putting the patient voice at the center of it,’” Andrew Pollack writes in the New York Times. 

“Today is my son’s first birthday, and I’m missing it because I am here desperately looking for help to recover what I have lost — a vital and beautiful part of my marriage,” Katherine Campbell told the panel. Pollack reports that her “travel expenses from Indiana were paid for by Sprout.”

Not all women or women’s groups agree with the panel’s decision on several accounts.

“Hypoactive sexual desire disorder was actually invented by pharmaceutical companies,” says Dr. Adriane Fugh-Berman of Georgetown University Medical Center, Maggie Fox reports for NBC News. “It was originally invented to sell the testosterone patch. And certainly there are women that have low libido, but that can be caused by many different things, including medications, such as the birth control pill and antidepressants and blood pressure medicines, for example.”

“No amount of slick marketing can get around the fact that at least so far drugs [like flibanserin] just don't work,” says Cindy Pearson of the National Women's Health Network, NPR’s Rob Stein reports. “Nevertheless, pharmaceutical executives hype the prospect of a ‘pink Viagra’ because the potential market is estimated to exceed $2 billion annually.”

“Others warned that the pharmaceutical company 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,’” said Liz Canner, a film maker who produced the documentary, “Orgasm, Inc.,” reports Brigid Schulte in the Washington Post.

But Even the Score, a coalition of 24 organizations “who believe that it’s time to level the playing field when it comes to the treatment of women’s sexual dysfunction,” cheered yesterday’s development.

“The FDA Advisory Committee made history for women's sexual health today by choosing to respect the science and stand with the millions of American women suffering from HSDD by opening the door to medical treatment options for their most common sexual dysfunction,” said Susan Scanlan, chair of Even the Score and chair emerita of the National Council of Women's Organizations, in a statement. “They rejected an unsustainable status quo where women have zero medical treatment options for their condition — while at the same time men enjoy 26 options marketed for their own sexual dysfunction.”

Sprout claims that about 33% of women in the U.S. “suffer from low sexual desire, and one in 10 women (16 million women total) are distressed by it,” in a news release applauding the decision and promising to work with the FDA on implementing a Risks Evaluation and Mitigation Strategy (REMS).

“HSDD is the most commonly reported form of female sexual dysfunction,” according to Sprout. “The condition has been medically recognized for more than 40 years and is characterized by a deficiency or absence of sexual fantasies and desire for sexual activity, which causes marked distress or interpersonal difficulty, and is not better accounted for by another disorder or to the effects of a substance.”

While it has been dubbed “the female Viagra,” scientists point out that the two drugs do entirely different things to the body. Flibanserin “increases downstream release of dopamine and norepinephrine while reducing serotonin release in the brain circuits that mediate symptoms of reduced sexual interest and desire,” David Kroll reports in Forbes. Viagra “acts as to increase blood flow to the penis to establish and maintain an erection.”