Advisers To FDA Recommend Agency Approve Drug To Boost Female Libido
Update 4:40 p.m.: The panel of advisers to the Food and Drug Administration voted 18 to 6 to recommend that the agency approve flibanserin, as long as there are measures in place to make sure that women are aware of its risks, including low blood pressure and fainting. The FDA doesn't have to follow the recommendations of its advisory panels but usually does.
A committee of medical advisers meets Thursday to consider whether to recommend that the Food and Drug Administration approve the first drug that aims to boost a woman's libido.
The FDA has twice before rejected the drug, called flibanserin, after previous advisory panels concluded there were questions about its safety and insufficient evidence that the drug was effective for women with low sex drives.
Sprout Pharmaceuticals, which makes flibanserin, has submitted more research that the company hopes will finally convince the advisers and the agency the drug is ready for the market. The company's evidence includes a study it says shows women can safely drive after using the medication. One concern about the drug is that it can leave women drowsy the day after taking it, increasing the risks for accidents.
"The review of flibanserin ... represents a critical milestone for the millions of American women and couples who live with the distress of this life-impacting condition without a single approved medical treatment today," Cindy Whitehead, Sprout's CEO, said in a statement before the hearing began.
Flibanserin, which the company plans to sell under the brand name Addyi if approved, shifts the balance of three key brain chemicals, increasing dopamine and norepinephrine and decreasing serotonin.
The drug has long been the focus of an intense debate. The company and some advocacy groups, including the National Organization for Women and Even the Score, have suggested that the FDA is being sexist by holding the drug to a higher standard than drugs, such as Viagra and Cialis, for male sexual problems.
The FDA denies those charges. In documents posted online in advance of the hearing, Hylton Joffe, director of the FDA's Division of Bone, Reproductive and Urologic Products, said that such claims "are misleading and inaccurate."
"The FDA rejects claims of gender bias," Joffe wrote. "The FDA's regulatory decision for each product is based on an assessment of whether the benefits outweigh the risks, and does not take gender into consideration."
Many women's health advocates agree with the agency's caution and remain opposed to the drug despite the company's new research.
"No amount of slick marketing can get around the fact that at least so far drugs [like flibanserin] just don't work," says Cindy Pearson of the National Women's Health Network. "Nevertheless, pharmaceutical executives hype the prospect of a 'pink Viagra' because the potential market is estimated to exceed $2 billion annually."
In the documents released in advance of the hearing, FDA reviewers concluded that the drug could boost libido in some women and increase the number of satisfying sexual experiences, but noted those effects are "numerically small."
According to the briefing documents, three studies that compared flibanserin with a placebo found that women using the drug had a median of 0.5 or 1.0 more satisfying sexual events a month, depending on the study. The median number of satisfactory sexual experiences each month before the drug test was two or three.
Some women's health experts argue that the campaign for flibanserin is oversimplifying female sexuality. Many women who experience a waning libido don't see it as a problem, these experts say. Moreover, a low libido may be a symptom of fluctuating hormones or of a health problem that needs attention, they add.
Some worry there could be serious side effects from long-term daily use of a the drug. And in the briefing documents, FDA reviewers highlighted side effects, including fainting and the increased risk for accidents, especially if the women combine the drug with alcohol.
"This drug is a combination of powerful brain neuromodulators prescribed for chronic use, with effects only appearing (if at all) after several weeks. This is in dramatic contrast to drugs like Viagra that are taken on an as-needed basis," says Leonore Tiefer, a New York University psychologist.
The company acknowledges flibanserin can have side effects, but maintains those are relatively minor and that the drug could help many women.
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Transcript
AUDIE CORNISH, HOST:
The Food and Drug Administration should approve the first pill designed to boost a woman's libido. That's the recommendation of an independent panel of experts the FDA assembled for a hearing today. NPR health correspondent Rob Stein has been following this story and joins us now with the details. Hey there, Rob.
ROB STEIN, BYLINE: Hey, Audie.
AUDIE CORNISH, HOST:
Let's start by talking about the drug itself. What's it called? How does it work?
STEIN: Yeah, this drug has been called flibanserin. Now, if the FDA actually goes along with this recommendation and approves the drug, the company says it's going to change the name and start selling it as Addyi. And here's how it works. It basically changes the levels of three hormones in the brain. It increases dopamine and norepinephrine and it decreases serotonin, and the idea here is it's supposed to increase the sex drive for premenopausal women suffering from something called hypoactive sexual desire disorder, which is basically a loss of libido.
CORNISH: And this isn't the first time the FDA's actually taken a look at this drug, right? I mean, tell us the history here.
STEIN: Yeah, actually this is the third time the FDA's considered this drug. Two previous times other FDA advisory committees rejected the drug, saying there just wasn't enough evidence that it actually worked and there was some concerns about side effects. Some women would - it caused their blood pressure to drop and they would faint. Some women, if they used the drug, would wake up the next morning feeling really groggy and drowsy, especially if they had drank alcohol while they were using the drug. And that was - caused concerns that it could increase their risk for accidents, like car crashes.
CORNISH: So did that actually fuel some controversy over this drug?
STEIN: Yeah. So the company that makes the drug and some outside advocacy groups, including, like, the National Organization for Women - NOW - basically accused the FDA of being sexist, saying they were demanding that this drug jump through many more hoops than drugs for male sexual problems like Viagra. And that that meant that the FDA just wasn't taking female sexual problems as seriously as male sexual problems and they pointed out that men who have sexual problems have many options. There are no drugs approved for women.
CORNISH: Now, Rob, what did the FDA actually say? How did they respond to these accusations, and then what about those experts?
STEIN: Yeah. So the FDA has flatly denied those accusations for a long time, and it did so again today during today's hearings. And they said, look, we've just been following the scientific evidence and there just wasn't enough evidence to approve the drug. And they got some support from some other groups, some women's health groups that basically agreed with them, saying, look, this drug doesn't seem like it works very well, if at all, and could have some serious side effects. And we have no idea what - if there are long-term side effects, women would have to take a psychoactive drug every day for the rest of their lives.
CORNISH: As for the hearing today, what happened?
STEIN: So it was a daylong hearing, and they heard a lot of evidence. The FDA scientist came in and they said, look, there is evidence that this drug can increase libido. It can increase the number of satisfying sexual experiences that women have and decrease the amount of stress they're experiencing, but they still were concerned about these side effects. And they said the effects - the benefits seem still to be modest. The company made its case and presented some new evidence saying, look, there's a lot - we've tested this drug on thousands of women. The effects may be modest, but for the women it helps, it helps a lot. It makes a big difference in their lives and that the side effects seem to be very mild and very rare. And there were some really - some very emotional testimony from women suffering from a loss of libido, describing how it had affected their lives, how it had affected their marriages, some risked getting divorced and they - really made them miserable. And then on the other side, there were advocates who were saying, look, this drug, you know, we really just don't know enough about it. The benefits seem so minor that it's not worth the risks. In the end, the committee voted pretty overwhelmingly 18 to six to approve the drug with the caveat that the steps be taken to make sure any risks were minimized.
CORNISH: What happens now?
STEIN: Well, the FDA doesn't have to follow the advice of its advisory committees, but it usually does.
CORNISH: That's NPR's health correspondent Rob Stein talking to us about a panel that's recommended that the FDA approve a drug to treat low libido in women. Rob, thank you.
STEIN: Oh, sure, nice to be here. Transcript provided by NPR, Copyright NPR.
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