Aug. 18, 2015 -- After two rejections and years of back and forth over its real benefits, the FDA on Tuesday approved the first medication designed to help women distressed about their lack of libido.
Flibanserin, which will be sold as Addyi, has a checkered regulatory history. In 2009, an FDA advisory committee unanimously voted against approval, because key clinical trials failed to show that it was significantly better than a placebo at improving women’s sexual desire. The FDA followed the panel’s advice and turned down the drug in 2010.
Drugmaker Sprout Pharmaceuticals reapplied to the FDA in 2013 with results from a new clinical trial, but the agency again rejected it. That spurred the company to help launch a campaign called “Even the Score” to press for approval.
Critics had charged the FDA with gender bias for failing to approve any drugs to improve women’s sex drive, a charge that divided women’s and health organizations.
An “Even the Score” petition urging the FDA to approve a drug for women with low libido collected more than 60,000 signatures. Some members of Congress also got involved, urging the agency earlier this year to approve the medication.
But not everyone jumped on the bandwagon.
“I’m a pro-sex feminist, but I believe that advocating for women’s health means finding solutions for women’s sexual problems that are safe and effective,” Cindy Pearson, executive director of the National Women’s Health Network, wrote June 8 in a Washington Post op-ed piece. “That hasn’t happened. Not yet.”
Pearson’s piece ran 4 days after an FDA advisory panel voted 18-6 in favor of recommending approval of Addyi.
In a statement Tuesday, the FDA noted "a potentially serious interaction" when combining Addyi with alcohol, and said women who drink alcohol should not take it. The drug can cause low blood pressure and fainting, the agency says, and those risks rise when Addyi is combined with alcohol or certain medicines. The drug will be available only through doctors and pharmacies who get training on the risks, the agency says, and it will carry a so-called "boxed warning."
That training includes a slideshow with an assessment afterward, Sprout CEO Cindy Whitehead told reporters Wednesday.
Q. Who can take Addyi?
It's the first drug approved for to treat premenopausal women with hypoactive sexual desire disorder (HSDD). That's the most commonly reported form of female sexual dysfunction, affecting 1 in 10 U.S. women. Simply lacking desire does not mean a woman has HSDD, though -- she also has to feel distressed about it.
“I think it’s hard to understand these women’s experience of having low sexual desire,” says Stanley Althof, PhD, executive director of the Center for Marital and Sexual Health of South Florida. He's also a Sprout consultant who worked on the testing of Addyi before its approval. “It’s very painful for them. They often come in desperate, thinking their marriage or their relationship is at risk.”
"This is really for women who have a biological dysfunction," Whitehead says. Women who are too stressed or tired to have sex, or have relationship issues, do not have HSDD, she says. "HSDD is, you had a normal desire at one point and you've lost it. It's actually been gone for some time."
In the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders, considered to be psychiatry’s “bible,” HSDD has been combined with female sexual arousal disorder to form the diagnosis of "female sexual interest/arousal disorder."
Some doctors might consider prescribing Addyi to women who have trouble getting an orgasm, Althof says, “but it’s not likely to be successful.”
Q. Addyi has been called the “female Viagra,” but are the drugs really that similar?
“Probably the most dangerous thing people can do when talking about this drug is to call it ‘female Viagra,’” says Walid Gellad, MD, who sat on the latest FDA advisory committee and voted in favor of approving Addyi. “It’s completely different.” Gellad is an assistant professor of medicine and of health policy and management at the University of Pittsburgh.
Althof agrees. The nickname is “clever, it’s cute, but it’s just factually incorrect,” he says. “You’re really looking at affecting brain chemistry vs. blood flow.”
Viagra and other meds for erectile dysfunction boost blood flow to the penis, but they don’t increase men’s libido. Addyi works on brain chemistry. It was originally tested as an antidepressant in men and women. It failed as an antidepressant, but women in tests of the drug said they felt more sexual interest, which led to it being studied as a sexual disorder treatment, Althof says.
Also, while men take Viagra and other erectile dysfunction drugs as needed, women are supposed to take Addyi daily, according to Sprout Pharmaceuticals.
Q. How well does it work?
“It’s effective. It’s just not very effective,” Gellad says.
According to data submitted in 2013, women who took Addyi for 24 weeks said they had an average of one more satisfying sexual event every 2 months than a comparison group of women taking a sugar pill.
That might not sound like much, but for women with the disorder, that’s “very meaningful,” Althof says.
At the advisory committee meeting, Sprout said it plans to recommend that women stop taking Addyi if they don’t feel more desire after 12 weeks, Gellad says. But because of the strong placebo effect seen in the clinical trials, “it’s highly unlikely that people will have no effect from this.”
"It doesn't treat all sexual dysfunction, it won't help all women with sexual problems, but it will have a role in the therapy," says Holly Thacker, MD, director of the Cleveland Clinic Center for Specialized Women's Health, in a statement.
"Addyi is not going to work for all women," Whitehead says, and drugmaker Sprout wants to "set realistic expectations in the marketplace."
Q. What are the side effects?
Besides the side effects when Addyi is combined with alcohol, the FDA also raised concerns about dizziness, fatigue, and fainting when women take the drug with hormonal contraceptives. There is also the potential for other side effects, the agency says.
Tests of the drug enrolled generally healthy women who weren’t taking other medications, such as sleep aids, that could worsen the side effects, Gellad says. At the advisory committee meeting, he says, Sprout said it planned to limit the number of prescribers by taking steps like not distributing samples for the first 1 or 2 years. The company also said Tuesday it would not advertise on television or radio for 18 months.
“If this medication can really help some women ... have it on the market in as safe a manner as possible,” Gellad says. “This drug should be restricted in whatever way can be done to ensure that only the people who really will benefit will get it.”
You take the drug daily at bedtime, Whitehead says. Taking it in the morning was linked to a higher risk of side effects.
Q. How much will the drug cost, and will insurance cover it?
Addyi will be available beginning Oct. 17, Sprout Pharmaceuticals says in a statement.
The drug's price hasn't been set yet, but it will likely be about the same as the monthly cost of erectile dysfunction meds for men, says Julia Cohen, a spokeswoman for Sprout. It's expected the drug will be covered by insurance with a copay of about $30 to $75 a month.