Drug to help women boost sex drive overcomes concerns over effectiveness and side effects, but some experts fear precedent campaigning could set

The FDA has finally approved the little pink pill to help women boost their sex drive.

Flibanserin, to be sold as Addyi, finally got a green light from the US Food and Drug Administration on Tuesday. This was the third time the agency has considered approval for the drug, which is intended for women diagnosed with hypoactive sexual desire disorder (HSDD).



The drug, while often referred to as “female Viagra”, is more akin to an antidepressant as it changes brain chemistry similar to the way that dopamine and serotonin do. Viagra relaxes muscles and increases blood flow to particular areas of the male body, helping treat erectile disfunction. While the blue pill for men should be taken before engaging in sexual activity, women are to take the pink pill daily.



“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

But the FDA cautioned that care should be taken for potential adverse reactions to the pill, including low blood pressure and loss of consciousness.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Woodcock said. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

According to Sprout Pharmaceuticals, which developed the drug, Addyi would treat “the most common form of female sexual dysfunction, affecting up to 1 in 10 women in the United States”.

“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” said Cindy Whitehead, chief executive officer of Sprout. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”

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In June of this year, the pill took the first step to making it into US pharmacies. An FDA panel voted 18-6 in favor of approving Flibanserin on the condition that Sprout develops a plan to limit safety risks. The panel had previously rejected the pill twice before.

When the FDA rejected Boehringer Ingelheim’s application for Flibanserin in June 2010, it ruled that the drug worked no better than a placebo.



“I certainly hope Boehringer doesn’t give up,” Sheryl A Kingsberg, a psychologist and Case Western Reserve University medical professor, told the New York Times at that time. “Flibanserin showed an awful lot of promise. I’m going to have some very, very disappointed patients if there’s nothing for them.”

Yet by October of that year, Boehringer did just that, announcing that it was discontinuing development of Flibanserin. Months later, in 2011, the drug was acquired by Sprout. The pharmaceutical company tried its luck before the FDA in June 2013, only to be thwarted when the agency ruled that the risks of sleepiness, dizziness, fatigue and nausea outweighed the benefits.

It was at about that time that the conversation about Flibanserin became heated, with opponents lobbying against the drug due to its side effects and supporters accusing the FDA of gender bias.

In October of last year, Sprout, along with number of organizations supporting the approval of Flibanserin, launched a campaign called “Even the Score”.

“There are 26 FDA approved drugs to treat various sexual dysfunctions for men (41 if you count generics!), but still not a single one for women’s most common sexual complaint,” the campaign argues on its website. “Why do we fast track the approval of drugs like Viagra (1998) for men?”

According to the campaign, sex is “a basic human right” and now is the “time to even the score when it comes to treatment of women’s sexual dysfunction”.

But a coalition of organizations led by the National Women’s Health Network wrote in a letter to the FDA: “The problem with Flibanserin is not gender bias at the FDA but the drug itself.” The group expressed support of the FDA’s “evidence-based evaluation and decision-making”.

Some healthcare experts, including Dr Adriane Fugh-Berman, a professor at Georgetown University, worry about how such campaigns might influence the FDA in the future now that Flibanserin has been approved.

“This may set a precedent of risky drugs being approved based on public relations campaigns rather than science,” she told Marketplace.

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“I think whether or not this is ultimately the right choice for women is a story that will be told in the marketplace,” Whitehead told Fast Company. Whitehead said that developing the drug and getting it approved became “a cause” for her.

Women suffering from HSDD also argue that it’s up to them to determine if the benefits outweigh the risks. Testifying before the FDA in June, a number of them urged the agency to approve the drug.

Amanda Parrish was one of the more than 11,000 women who have participated in Flibanserin’s trial. Prior to joining the trial, she would try to avoid her husband, Ben, come bedtime. After she began taking Flibanserin, she said she did not feel any different during the day but her evenings turned around.

“What it did do was at the end of a long day, no matter how tired I was, I wanted to initiate and it was not work to do that,” she told NBC Nightly News.

“She was flirty again. She was leaving me notes on my bathroom mirror in the morning,” said Ben Parrish. “We know that it works. We experienced it.”