Why I Hope The FDA Approves “Female Viagra”

The US Food and Drug Administration has now approved the first drug in the United States to treat a low libido in women. Nicknamed the “female Viagra,” flibanserin is said to treat hypoactive sexual desire disorder, or a persistent lack of sexual desire in premenopausal women. (Despite the nickname, the drug functions differently than Viagra it targets chemicals in the brain rather than increasing blood flow to the genitals.) The so-called disorder is said to affect nearly 1 in 10 women.

But safety restrictions on the daily pill, called Addyi, mean it will probably never achieve the blockbuster sales of men’s impotence drugs like Viagra, which have generated billions of dollars. The new drug’s label will carry a bold warning that combining it with alcohol can cause dangerously low blood pressure and fainting. Those problems can also occur if the drug is taken alongside certain common medications, including drugs used to treat yeast infections.

The Food and Drug Administration approval on Tuesday marks an unusual turnaround for the agency. The FDA previously rejected the drug twice due to lackluster benefits and worrisome side effects. When it comes to problems in the bedroom, men have long had several pharmaceutical options but women were typically out of luck. That begins to change today.

What is ‘female Viagra’? Is it safe? And what happens next?

Also unlike Viagra, which is taken on an as-needed basis, flibanserin is effective only if taken every day. Because the drug can cause sleepiness, Sprout recommends taking it before bed. Adriane Fugh-Berman, a pharmacology professor at Georgetown University and director of Pharmed Out, which focuses on pharmaceutical marketing practices, called Tuesday “a sad day for drug regulation.”

“The FDA turned down this drug twice because the risks outweighed the benefits,” she said. “What has been learned since the last disapproval is that it has more risks than we thought and it doesn’t have any more benefits. The only thing that’s different is a clever, aggressive public relations campaign that Sprout Pharmaceuticals waged successfully.”She added: “This opens the way for drug companies to pressure the FDA through public relations campaigns to approve more bad drugs: It’s bad news for rational drug approval.”

The FDA rejected the drug in 2010 and in 2013, saying the risks of side effects such as nausea, dizziness, low blood pressure, fainting and sleepiness outweighed the “modest” benefit. In June, however, an FDA advisory panel voted 18 to 6 to recommend approval. That vote came after Sprout conducted additional safety testing and measured the drug’s impact on sexual desire over 28 days, not daily as in earlier studies. The FDA concluded there was a “statistically significant” improvement over a placebo.

Prior to flibanserin, there had been no FDA-approved treatments for Hypoactive Sexual Desire Disorder, first described in medical literature in 1977. Surveys show that low libido is the most common female sexual dysfunction. Counselors say it is also the most difficult to treat.

Sally Greenberg, executive director of the National Consumers League and a member of the Even the Score advocacy campaign, praised the FDA decision. “It acknowledges that as a condition, HSDD is not simply a psychological problem or a reflection of cultural pressure on women but a biological condition that can be treated with an effective medication,” she said.

 “Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

The drug itself, however, is controversial. Since 2010 the FDA has twice rejected Flibanserin, most recently in 2013 due to its negative side effects. While proponents of the drug say it could help women who feel they have no other option, critics argue the pharmaceutical industry is trying to solve a perceived problem that may be far more complicated, or not, in fact, a problem at all with a quick fix in pill form.

Some doctors, patients, and activists, however, see the imbalance between medical options for men and women as sexist. The FDA has labeled female sexual dysfunction as one of the top disease areas ripe for treatment. Now, Sprout Pharmaceuticals says, there is one.

“For too long, we have wanted to say, ‘Women are so complex, sex is complex.’ Sex is complex whether I am a man or a woman,” says Sprout chief executive Cindy Whitehead. “And so for women that have lost desire that they used to know, causing either personal or interpersonal distress, while all other factors are going well, those are the women for whom this treatment could offer help.”

And yet critics worry that flibanserin may cause more problems than it will help. Some researchers argue that the drug’s side effects, which include drowsiness and nausea, do not outweigh its moderate benefits. Unlike sildenafil (the generic name for Viagra), which men can take in single doses, women are supposed to take a daily dose of flibanserin, potentially putting them at risk for side effects from mixing the drug with normal activities, including drinking alcohol. Others add that the drug has not been proven to be much more effective than a placebo.

“Flibanserin can cause serious harms, including unpredictable hypotension and sudden unconsciousness, and its adverse effects are exacerbated by alcohol, oral contraceptives, antifungals, triptans and many other drugs,” a team of around 200 researchers said in a letter sent to the FDA earlier this year, demanding that the agency reject the drug.

Nonetheless, the FDA voted to approve it, despite citing an increased risk of low blood pressure or loss of consciousness when the drug is mixed with alcohol or certain other drugs. “Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Woodcock said.

Yesterday the FDA approved Flibanserin, to be sold as Addyi, to treat low sexual desire in women. The media, likely taking cues from the drug’s maker Sprout Pharmaceuticals and women’s rights groups, have dubbed the drug the “female Viagra,” an oddly inaccurate nickname that seems to have stuck.

The medical community has in turn argued that Flibanserin is anything but the female Viagra, given several factors, not the least of which is the organ that it targets  the brain, rather than the genitals. Beyond this, its relatively low efficacy, high risk of side effects (especially when taken with alcohol) and lack of knowledge about how it works has given some experts pause. For women who are trying to decide whether the benefits will outweigh the risks, they’ll certainly have their work cut out for them, as they sift through the hype to get to the science.

One positive aspect of the drug’s approval that few dispute is the significance of the fact that a sex drug for women was approved at all. “The Flibanserin approval is a landmark moment,” says Kim Wallen, sex researcher and professor of psychology and behavioral neuroendocrinology at Emory University. “Not because it is an effective or necessarily a safe drug,” he adds, “but because it is the first time, to my knowledge, that a drug has been approved strictly to improve sexual desire.

Contrary to Sprout’s lobbying effort, there have been no drugs that directly addressed sexual desire for either men or women. This legitimizes sexual desire as an important part of women’s lives and justifies treatment for low desire if the woman is interested in increasing her sexual desire. This is a real sea change in thinking about sex and drugs.”

But that’s where the accolades end. The reality is that Addyi and Viagra are only vaguely related  they both fall under the general umbrella of “sex,” but that’s about it. Viagra treats erectile dysfunction (ED) by affecting the mechanics of sex, relaxing the blood vessels of the penis so that an erection can occur.

Addyi, or Flibanserin, works on the brain, under the auspices of targeting sexual desire in the first place but it’s more closely related to antidepressants than to ED drugs. “Viagra does not affect sexual motivation,” says Wallen, “except for the effect that a man with erectile dysfunction may be more interested in sex if he knows that he can reliably get an erection… Flibanserin is not the female Viagra and the constant use of this term reflects that few understand what it is that Viagra does and why Flibanserin is so different.”

In fact, we really don’t know not only how or why the drug would work, but we also don’t know enough about how the neurobiology of sexual desire works to design a drug to address it. “We know that hormones have something to do with it as in both men and women when they lose gonadal function desire generally lose sexual desire,” says Wallen, “but we also know that many other non-biological factors influence desire pay raises, vacations, a new partner.

 In general these non-biological factors produce more profound effects than do any of the proposed biological treatments. The reason that Flibanserin is so marginally effective is that no one actually knows what could work or why it would work.”

The drug was rejected by the FDA once in 2010 and again in 2013, citing ineffectiveness and a too-high risk for side effects. Now approved, after much lobbying from Sprout and women’s groups like “Even the Score,” the drug still carries strong warnings, namely of episodes of extreme low blood pressure and syncope (fainting), especially when taken with alcohol. In fact, doctors are strongly urged to talk with their patients about the seriousness of that contraindication – which may be a big consideration for some women who enjoy an occasional drink, since the drug is taken every day, not just on an “as needed” basis like Viagra.

And perhaps the bigger concern is the ho-hum efficacy the drug seems to have. In clinical trials, somewhere between 9% and 14% of women taking the drug responded to it. And these women had on average an increase of 0.5 to 0.7 “sexually satisfying events” per month compared to placebo. That doesn’t sound like much.

That said, my colleague David Kroll points out that if even 10% of women respond to the drug, of the 16 million women who are thought to have low sexual desire, that would mean that 1.6 million might be helped. But whether the benefits outweigh the risks when you’re talking about having one extra “sexually satisfying event” per month is unclear.

“Looking at Flibanserin on its merits, it does not appear to be a very effective drug,” says Wallen. “A majority of Flibanserin’s effect appears to be due to a very large placebo effect. Were Sprout to market the placebo they would have a drug as effective as the active compound with no safety concerns. Of course, the FDA won’t approve a placebo, but it is striking how large is the placebo effect. I suspect that this means that many women who take the drug will initially notice a change, but that after 3 months, or 6 months, or a year they will notice that their libido is right back where it started.”

Part of the problem is that researchers can’t seem to agree on what sexual desire is in the first place, let alone how it works in the brain. Some sex researchers feel that all female sexual desire is reactive a response what’s happening around them rather than a something that can just exist on its own.

“In their view, what Flibanserin supposedly treats, lack of spontaneous sexual desire, doesn’t exist.” Wallen adds that he disagrees with this theory, and believes, as do the makers of Addyi, that there’s also a state of desire, which we call “horniness.” But because so much of sexual desire is based on context and other psychosocial factors, focusing on these elements, he says, has more promise than focusing on a biological system that we don’t really understand.

“In my view, if context can change desire then at some biological level it is changing the expression of the biological mechanism that creates desire,” says Wallen, “but what that mechanism is I have no clue, and neither does any pharmaceutical company. Of course I suspect Sprout could care less. Their goal is not to treat low sexual desire, but to make lots of money and in that they are very likely to succeed. They will get rich leaving many disappointed women in their wake.”

Finally, there’s a psychological element to the issue that’s not been mentioned so much: How it will affect the relationship between the women who’s considering taking it and her partner. Wallen points out that an unexpected consequence of Viagra was that it destabilized some of the couples who had adjusted to the man’s ED. In some cases, he says, “the return of male erectile capacity was desired by the man, but not the woman, and increased sexual pressure on women in relationships where sex had become a smaller part of that relationship.

 In the case of Flibanserin, I wonder who will be the one desiring that the women take the drug. Will they all be women seeking to increase their interest in sex, or will it be husbands pressuring their partner to increase their wife’s sexual desire? The drug was created to address very low sexual desire. What will be the incidence of women with typical libido being pressured into getting this drug to enhance their desire? I wonder how this will change the dynamics of couples.”

So does it really “even the score,” as the women’s groups have pushed at so hard? It’s certainly not clear at this moment in time. You could even argue that it make the score more disparate, since Sprout and its fans are celebrating a drug with low efficacy, significant side effects, and a poorly understood mechanism of action. But for the small portion of women it does help, perhaps it will make a difference.

And perhaps its very existence will prompt more research into the area of sexual desire at present, the National Institute of Mental Health doesn’t fund research like this because it doesn’t consider the issue a mental health issue. “If Flibanserin does open the doors to research in sexual desire then it will serve a very valuable purpose,” says Wallen. “I fear, though, because of its ineffectiveness that it will eventually be seen as a drug that didn’t work and that will be the end of the story. I hope I am wrong.”

Out of desperation, women were turning to unproven, unregulated treatments  

Marianne Brandon, a sex therapist in Annapolis who served on the FDA advisory panel and voted to recommend approval of the drug, said low desire, like depression, is physiological as well as psychological and emotional. And, she said, as with depression, therapy can help but might not be enough. “Turning low libido around, without having a biological component to your treatment like a flibanserin, is difficult,” she said.

Leonore Tiefer, a sex therapist who has been leading the New View Campaign against flibanserin and other drugs, said she was “disappointed but not surprised” by the FDA decision. “It’s interesting that the FDA made it so you’re going to have to jump through quite a few hoops to get this drug,” she said. “They’re asking health-care professionals to assess the likelihood of the patient reliably abstaining from alcohol. Well, that’s asking too much, if you ask me.”

Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, sat on the FDA advisory panel and voted against approval of the drug. More than half of pre-menopausal women drink regularly, he said, citing testimony at the June hearing, and 30 percent report binge drinking. “Given the prevalence of alcohol use and abuse in our society,” he said, “I think it’s alarming that this product’s interactions with alcohol aren’t better explored before it’s approved for the market.”

Alexander said one of the main differences in the FDA’s previous rejections of flibanserin and its approval Tuesday was the high-profile Even the Score campaign, which ran TV ads, lined up several members of Congress and gathered more than 60,000 signatures to press the FDA to approve the drug.

Whitehead said Sprout has already completed studies to test the effectiveness of the drug in post-menopausal women a potentially huge market, with the growing number of aging female baby boomers. Libido naturally drops with age as hormone levels fall. The company will begin working toward FDA approval for older women, Whitehead said. “This could have a real-life impact and be a real change for them,” she said.

FDA analysis of the outcomes of flibanserin clinical trials found “small but statistically significant” improvement in sexual desire and satisfying sexual events, and lower levels of distress.

“Our goal is not to move someone who rarely or never has interest in sex to wanting sex most or all of the time,” Whitehead said. “We’re aiming to bring her back into normal range.” That’s all Katherine Campbell, 31, a mother of two young boys in Noblesville, Ind., says she wants. She said when she heard the news about the FDA approval, she started to cry. “Oh, mygosh, I’m so excited. I cannot wait to try it,” she said. “I know millions of other women are out there waiting to get their hands on it, too.”

Are we ‘medicalizing’ sex?

And if flibanserin does not work, there are several other drugs aimed at boosting women’s craving for sex already in the FDA pipeline.

Carl Spana, president and CEO of Palatin Technologies, said the FDA approval was “a big positive” for drugs such as the one his company is developing, bremelanotide, which works on melanocortin receptors in the brain to boost female sexual desire. “Women need other treatment options,” he said. “The decision really sets a regulatory precedent for how the FDA will measure efficacy moving forward.”

Spana hopes to submit the drug for FDA approval in 2017 and put it on the market by 2018.

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