Women, doctors say better treatments for sexual dysfunction needed
Controversy over a drug to boost women's libido has brought to light the overwhelming need for new ways to treat sexual problems in women.
The U.S. Food and Drug Administration announced its decision late Tuesday to approve the drug, called flibanserin. And while it may be welcome news for many dissatisfied with their sex lives, it will still be only one option, and experts say a limited one, at that.
In clinical trials, women taking the drug reported about one additional "sexually satisfying event" per month, and scored higher on questionnaires measuring desire - a relatively modest level of improvement.
Unlike Viagra, to which it is often compared, flibanserin works by altering chemicals in the brain.
"It increases dopamine and norepinephrine. Both of those are responsible for sexual excitement," Dr. Michael Krychman, a gynecologist and Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine, told CBS News. "Then it decreases serotonin, which is really about inhibition."
Flibanserin, which will be marketed under the brand name Addyi, will be the first and only FDA-approved medication for hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is defined as "persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity" that causes "marked distress or interpersonal difficulty," according to the Diagnostic and Statistical Manual of Mental Disorders (DSM), the standard guide consulted by doctors.
About one in 10 women suffer from HSDD, according to Even the Score, a women's sexual health campaign that has advocated for flibanserin's approval. The drug's manufacturer, Sprout Pharmaceuticals is one of the campaign's supporters. Other surveys estimate that 8 to 14 percent of women ages 20 to 49 have the condition, or about 5.5 to 8.6 million women in the United States.
While the treatment options for men are plentiful, there has been no equivalent for females.
"For women with low sex drive, there's really not very much," said Dr. Holly Thacker, Director of the Cleveland Clinic Center for Specialized Women's Health. "Certainly there's counseling, sex therapy, making sure there's not relationship issues or hormonal issues, having privacy and making sure the woman has enough time for herself."
Krychman emphasized that therapy can be an important component for treating the condition. "Behavioral therapy certainly does work, prioritizing sexual experience," he said. "Sometimes I prescribe what's called a digital fast. We need people to get off their phones and iPads and look at each other in the eye and sit face to face communicating with one another, spending time and physical intimacy together."
Some people believe certain foods or natural supplements can increase desire, but there is little evidence to support those claims.
Last month, Krychman and a colleague released a review of some of the most popular and currently used supposed aphrodisiacs in the United States. While there was some preliminary evidence that certain products, such as ginseng and Ginkgo, have some benefits for sexual desire, the data was limited, and the majority of aphrodisiac claims, including those for chocolate, honey and oysters, were unfounded.
"It's interesting because it really points to the huge, unmet need. Desperate people do desperate things," Krychman said.
Flibanserin will be far from a cure-all for sexual dysfunction in women, experts say. "It's not an aphrodisiac, it's not a medication that's going to cure personal or relationship issues, it's not going to help women who are hormonally deficient," Thacker said.
Despite those limitations, Sheri Mike, a 34-year-old mother of two, told CBS News she's willing to give the drug a try. "I've tried vitamins, me and my husband have tried counseling, I've tried hypnotherapy, but none of those have worked," she said.
There are concerns about side effects from the drug, including low blood pressure, fainting, drowsiness and dizziness, especially when combined with alcohol and certain other medications. One in 5 women experience an adverse effect while taking the drug, Dr. Adriane Fugh-Berman of Georgetown University told CBS News. The FDA's approval came with a requirement that the drug carry a boxed warning on the label about the risks.
But some experts say even with those downsides, women need to have the choice available to them.
"With this decision, hopefully, women, in conjunction with women's health care providers, can be appropriately evaluated and make the decision that's right for them," Thacker said. "In 2015, we need to be able to offer some more options to women."
Krychman acknowledged that the pill won't be right for everyone, but he believes it is still an important option for women to have. "Women deserve the choice, just like men," he said.