The Problem with "Female Viagra" 2017-01-25
When Addyi, a drug intended to recharge female libido, got a thumbs-up from the FDA in August 2015, its manufacturers hailed it as the biggest sexual health breakthrough since the pill. More than a third of adult women have low desire, according to a 2008 study from the journal Obstetrics & Gynecology, and this is estimated to cause distress in 9.5 percent of them. Addyi was created to help those women who are bothered by a fizzling desire that can’t be attributed to any other cause (like a medical or psychiatric condition or relationship problems).
But after more than a year on the market, the drug doesn’t seem to be turning many women on. The number of prescriptions averaged 1,600 per month during the first half of 2016, a paltry figure compared with the million-plus issued for male erectile dysfunction drugs. One reason “female Viagra” has gotten a lukewarm reception: It’s not female Viagra. Erectile dysfunction drugs solve a physical problem; Addyi ventures into the subtler, thornier realm of desire. Lab studies suggest it works by increasing levels of dopamine and norepinephrine and dampening serotonin levels in certain areas of the brain—and that’s making women leery.
“I have a handful of patients on Addyi, but women with low desire—even those who are really distressed about it—may say, ‘I don’t want to take a pill to feel the urge to have sex,’” says Sharon Parish, MD, a sexual-medicine specialist and professor of medicine in clinical psychiatry at Weill Cornell Medicine in White Plains, New York. “As a culture, we’re becoming warier of medical solutions for issues that don’t feel like medical problems.”
Another source of concern is Addyi’s health implications. Unlike Viagra, which a man can pop up to four hours before sex, Addyi is designed to be taken nightly, though a woman may not feel the benefits, if any, for four to eight weeks. And it may cause sleepiness and dizziness, both of which can be exacerbated by alcohol. The FDA was so concerned about the Addyi-alcohol interaction, it put a “black box warning” on the drug and requires doctors to have patients sign a form stating that they understand they can’t drink at all—not even a romantic glass of wine—without risking a dangerous drop in blood pressure. “This is a drug that the FDA rejected twice before approving it because its risks outweighed its benefits,” says Lisa Schwartz, MD, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice. “Many women are clearly looking at the downsides and saying no thanks.” The final side effect? A much emptier wallet: Addyi is priced at around $800 per month. Because of its high cost, some insurance companies refuse to cover the drug or they make it difficult to qualify for reimbursement, sometimes requiring a psychiatrist visit first (unlike erectile dysfunction drugs, which are relatively easy to obtain and covered by some plans).
Even if a woman decides to commit to Addyi, it may not make a significant difference in her life. In studies submitted to the FDA, around 10 to 15 percent of women taking Addyi had a moderately strong response, but there’s no way to tell which women will have this result, says Lori Brotto, PhD, a clinical psychologist and executive director of the Women’s Health Research Institute at the University of British Columbia. “A recent review of clinical trials found that compared with women given a placebo, overall those taking Addyi had one additional satisfying sexual event, on average, every two months,” she says. “For some women, that small improvement might make a difference, but I would argue that for most, it’s not enough to justify taking daily medication.”
Some doctors are more enthusiastic about Addyi’s potential. Gynecologist Lauren Streicher, MD, author of Sex Rx: Hormones, Health and Your Best Sex Ever, thinks it could help some of her patients. “Addyi isn’t a perfect drug, but it can be beneficial for a specific group: premenopausal women who enjoy sex and are unhappy when their libido switch mysteriously flips from on to off,” says Streicher. Addyi was submitted for FDA approval based only on the drug’s effects on premenopausal women. However, a June 2014 study in Menopause found that postmenopausal women experienced a statistically significant response to Addyi compared with a placebo treatment, and Streicher says the drug has helped some of her postmenopausal patients, too. “Of the ten or so pre- and postmenopausal women I’ve prescribed it to, about half have had a significant enough response to continue taking it,” Streicher says. “At the very least, Addyi has women talking to doctors—and others—about the issue of low desire,” she says.
These next-gen therapies could be much sexier than they sound:
This self-injectable drug targets brain receptors involved in bolstering desire in response to sexual activity. In a clinical trial, it offered users one extra satisfying event every two months. It will likely be submitted for FDA approval next year.