HOW DOES IT WORK?
Addyi, known generically as flibanserin, acts on brain chemicals associated with mood and appetite, similar to antidepressant drugs. In fact, it was originally studied as a treatment for depression before being repurposed into a libido drug. It’s not entirely clear why the drug increases sexual desire but researchers point to its ability to increase dopamine — a brain chemical associated with appetite — while lowering serotonin — another chemical linked with feelings of satiation.
WHO WILL TAKE THIS DRUG?
The FDA approved Addyi for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress.
Surveys estimate that between 5.5 million to 8.6 million U.S. women have the condition, or roughly 8 to 14 percent of women ages 20 to 49. Because so many other factors affect sexual appetite, there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship problems, medical conditions and mood issues caused by other medications like sleeping aids and painkillers.
The diagnosis is not universally accepted and many psychologists argue that low sex drive should not be considered a medical condition.
I’VE HEARD THIS DECISION WAS CONTROVERSIAL, WHY?
The drug followed a long, contentious path to approval, including two previous rejections by the FDA. For years, two opposing sides have argued over the fate of the drug.
On one hand, drugmakers and some medical experts argue that women need FDA-approved medications to treat sexual disorders, which they consider serious medical problems. On the other side, consumer-safety advocates have said the drug’s side effects are too risky, and there are those who question whether low libido is a medical condition.
On top of this debate, Sprout Pharmaceuticals enlisted outside politicians and women’s groups to lobby the FDA to approve the drug.
DOES THE DRUG WORK?
Experts usually describe Addyi’s effect as “modest.” In company studies, women taking flibanserin reported a slight increase in sexually satisfying events each month. Their answers to separate questionnaires indicated they experienced a slight increase in desire and a slight decrease in stress.
While FDA scientists describe these effects as “small,” they were significant enough to meet FDA effectiveness standards.
WHAT ARE THE SIDE EFFECTS?
About 10 percent of patients in Sprout’s studies experienced the most common problems: dizziness, fatigue and nausea. The drug will also bear a boxed warning that women should not drink or take certain types of other medications, including antifungal drugs, because of an interaction that can cause low blood pressure and fainting.
HOW MUCH WILL IT COST?
Sprout says women who have health insurance will pay between $30 and $75 for a month’s supply of Addyi, depending on their coverage terms.
WHY DID THE FDA APPROVE ADDYI THIS TIME AROUND?
When FDA regulators first rejected Addyi in 2010 they noted that the drug failed to achieve a key study goal — increasing desire based on patients’ daily journal entries. Because of that lack of effectiveness, they said, the drug’s negative side effects outweighed its benefits.
Since then, Sprout conducted another study of sexual desire using a different method that achieved statistical significance. The company also conducted several safety studies to more clearly define the drug’s risks, which are outlined in its warning label.
While the FDA is required to make all decisions based on science, critics say that the concerted lobbying effort by Sprout-funded supporters also played a role in Addyi’s approval.
WHEN WILL THE DRUG BE AVAILABLE?
Sprout plans to launch the drug in mid-October.
Several local doctors lauded the recent approval of the first commercial medication designed to boost female libido, but they also warned against unrealistic expectations and potential side effects of the new drug, nicknamed the “female Viagra.”
Flibanserin, from North Carolina-based Sprout Pharmaceuticals, is designed to stimulate the brain to improve lagging libido in women who suffer a condition called hypoactive sexual desire disorder.
It was given the green light by the U.S. Food and Drug Administration on Tuesday, joining Viagra, Cialis and dozens of other medications that have been FDA approved to treat sexual dysfunction.
But unlike Viagra, which can be taken as needed and has been proven effective in helping most men achieve an erection, Flibanserin can take up to a month to work and only about 10 percent of women experienced improved sexual desire in clinical trials.
“Efficacy has not been overwhelming,” said Dr. Jeremy Groll, an obstetrician-gynecologist at SpringCreek Fertility in Centerville. “It’s certainly no panacea, and it’s not a medicine that’s going to work for everybody. But for some people it may be a useful agent.”
Still, Flibanserin — which will come in the form of a pink pill sold under the brand name Addyi — could be a first step toward bridging the cavernous gap between treatments for women and men, Groll said.
“Right now, there are over 20 approved medicines for male sexual dysfunction, but zero agents approved for female sexual dysfunction,” he said. “From that standpoint, there is clearly a tremendous void in medical treatment for the large number of women who suffer from a physiological decrease in sexual desire.”
Dr. Steven Lindheim, a professor in the department of obstetrics and gynecology at Wright State University’s Boonshcoft School of Medicine, anticipates strong demand for the drug from the estimated 16 million women who suffer from HSDD.
But under the FDA guidelines, the drug will only be available through specially certified health care professionals and certified pharmacies and will carry a label warning against potential side effects, including severely low blood pressure and loss of consciousness when taken with alcohol.
“The FDA took its time in approving this and being cautious about ensuring providers are not haphazardly trying to prescribe the medication,” Lindheim said. “But I think it’s really important to address the issue of HSDD. To not address it wouldn’t be fair, and the current therapies that we have really aren’t super great. The bottom line is that this gives us another tool in our arsenal to treat women.”
It also opens a potentially lucrative market opportunity for doctors and pharmacies.
“The demand for these kinds of medications is just as high with the female population as it is with the male population, but there hasn’t been anything on the market for women until now,” said Kindy Ghussin, owner of Heartland Pharmacy in Kettering. “I would expect there to be a lot of inquires and to fill a lot of prescriptions.”
According to a recent survey from health industry data tracker, Treato.com, 73 percent of female survey participants said they were likely to discuss low sex drive with a doctor or pharmacist, and 80 percent indicated they’d be willing to take Addyi to improve low sex drive.
Still, the market for Addyi probably won’t be as robust as the multi-billion market for men’s sexual enhancement drugs, largely because of the social stigma for women and the out-of-pocket costs, Ghussin said.
“I don’t see women bringing prescriptions to the pharmacy as readily as a guy would,” he said. “And I can tell you for sure, (Addyi) is not going to be covered by insurance because Viagra has been out for almost 20 years, and it’s not covered.”
Most health insurance companies don’t cover drugs to treat erectile dysfunction, and those that do charge exorbitant co-pays for such medications, Ghussin explained.
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