Don't Call It "Female Viagra", And More Misconceptions About Addyi And The Disorder It Treats

As you may have heard by now, the FDA approved Flibanserin, which will be marketed as Addyi and be available by October 17. It's opened up the issue of female sexual dysfunction to the great world wide web and beyond. While many health advocates praised the decision, calling it a victory for women's sexual health, others have not been as enthused, citing the drug's past history of FDA rejections and questioning its usefulness, among others.

Cindy Whitehead, CEO and co-founder of Sprout Pharmaceuticals, the company that makes the drug, tells Bustle that after a Food and Drug Administration advisory panel voted to recommend the federal agency approve the drug back in June, that it was amazing to see patients, husbands and doctor's around the country talking about the women's rights issue. "Then you see headlines like, 'Is this a date-rape drug?' Which makes no sense based on how it works. The only people it hurts inevitably, are the women and the conversation that we should be having," says Whitehead.

Regardless of where you personally stand on the issue, whether you believe in its use or not, there's been a lot of information and commentary going around lately about what Addyi is, what it does, is there a really a need for it, and so on and so forth. Despite all the talk going on out there, it's difficult to get a grasp of what the little pink pill is without getting mixed up in all the misinformation.

Bere's what you should know about Addyi and the disorder it treats.

The Basics

It's meant for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. It's a non-hormonal pill that's taken at bedtime. It is one of the most studied women's health products in history, being studied in over 11,214 women.

Hypoactive Sexual Desire Disorder: The Basics

Approximately one in three women in the U.S. suffer from low sexual desire and one in 10 are distressed by it. It's defined as a persistent to recurrent deficiency or absence of sexual fantasies and desire for sexual activities that causes distress and difficulty, and it not caused by any other psychiatric disorder, substance, or medical condition.

HSDD is the most common form of female sexual dysfunction and affects about seven percent of all U.S. women from ages 18 to well into their 60s and 70s.

Despite What People May Think, HSDD Is A Real Thing

"I’ll draw the parallel to depression," Whitehead says. "Before there were medical treatments for depression, we said it’s all in someone’s head, right? Life is hard. Then we realized that there can be a group of people who have a brain chemistry imbalance and access to medical treatment can mean huge differences in their lives and functioning. HSDD is no different. My hope is when we now have brain scans, when we know that this work isn’t just the first work, that it’s multiple studies and that it’s been completed at Stanford and at Brown – all of these have appeared in scientific literature – that we’ll start to move away from some of those societal condition bias and really look at the medical condition for what it is."

What's changed over recent years is that more and more women are speaking out and having their voices heard.

"I think what’s been fundamental is really hearing directly from patients themselves. Putting the patients' voices in the center of the conversation. Who knows better than the women who are living with this about what they’re going through? They’ve been medically diagnosed with a diagnosis that’s existed for 30-plus years and they’re sitting there telling us they’re experience, so I really can’t imagine the critics having sat in a room and having heard these patients but seem to perpetuate a lot of this misinformation."

Speaking Of Misinformation, Don't Call It "Female Viagra" Because It's Not

In fact, the woman behind the pink pill says that's one of the drug's biggest misconceptions.

"The biggest misconception is that we're 'female Viagra,'" Whitehead said. "I get why people say that by context because that was kind of the drug that changed the conversation around men's sexual health and opened the doors for a lot of treatment options to come forward. But they don't work the same."

According to Whitehead, Viagra addresses a blood flow or mechanical issue for sex because of erectile dysfunction. For women, it's all about desire and that's in the brain. Addyi works on those key chemicals in the brain.

How It Works:

The drug targets key neurotransmitters in the brain that impact sexual response. It is believed to have positive effects on chemicals involved with sexual excitement such as dopamine and norepinephrine, and have negative effects on chemicals involved with sexual inhibition such as serotonin.

Whitehead says:

"In 2009, there was some spectacular new science. There were PET scan imaging of the brain of women with HSDD and they were contrasted to women who did not report the condition. So we put those women in the PET scan, exposed them to some erotic stimuli, and watched how their brains lit up or didn't. The lighting up is really the brain is quieting to go into the sexual experience. So you see a stunning contrast between women deactivating, the women who don’t report having the condition, to women with HSDD, the women who don’t deactivate. The brain doesn’t sort of quiet to go into the sexual experience to let the brain take hold. Where flibanserin is working is really masking what we really understand scientifically. Its mechanism is its key chemicals involved in the prefrontal cortex. It’s a cool new understanding in terms of desire."

In short, the brain imaging studies found that women with HSDD had different prefrontal brain responses to sexual stimuli than those who did not report to having low sexual desire.

Addyi Takes Time

All those headlines you might read saying, "Is this a new date-rape drug?" are quite simply, a bunch of BS. In fact, Dr. Sheryl Kingsberg, a clinical psychologist and associate professor in both the Departments of Reproductive Biology and Psychiatry at Case Western Reserve University School of Medicine in Cleveland, OH, tells Bustle that the drug takes some time to have any effect, up to four weeks.

"It's not something you can slip into someone's drink. Even if any drug — and not flibanserin, which wouldn't work that way because it takes time — even if you have an on-demand drug, it doesn't make you non-discriminating. You'd still be able to know a jerk from a non-jerk. It can't work as a date-rape drug because it doesn't have an immediate quality. It doesn't knock you out."

It's All About Restoring Sexual Desire

According to Dr. Kingsberg, who's been involved in the clinical trials and serves as a consultant to Sprout, Addyi is used to restore something that's been lost.

"The idea is that it restores women who had desire and lost it, to their baseline levels. We’re not looking to create hypersexuality. The idea is to get women who have no desire to what they used to have which is sometimes having desire. To move them from not having desire to having desire all the time is not something that the FDA would approve of and it’s certainly not what women are looking for. I joke and I say, it’s not like we’re trying to turn them into men to think about sex every minute. We’re trying to restore them to what they had at baseline."

It's Up To You To Decide If The Risks Outweigh The Benefits

"If you put Flibanserin next to any CNS drug -- because let’s be clear, this is a CNS drug, it works in the brain in the neurotransmitters -- if you look at it compared to any CNS drug that has been approved in the last 20 years, you would say, 'Wow, that safety profile is great,' Dr. Kingsberg says. "This is not a dangerous drug. There’s no drug that comes without side effects or any risks. We leave it up to women to be informed. I think it’s paternalistic to deny women these options."

Why Are There 20+ Treatments For Men's Sexual Dysfunction And None For Women?

According to Whitehead, it's because we tend to oversimplify sex.

"I think that as a society, we’re really quick to reduce all things in the bedroom for men to biology, as witnessed by all the treatment options available to them. All things related to sex for women, to psychology. And if we do that, we’re actually underselling both. You know, sex is complex. We bring a lot of things into the bedroom. We bring our religion, our upbringing, we bring what’s going on with us personally, what’s going on in the relationship. But men and women alike bring biology into the bedroom and that’s where women have been really under served. So if you look at Hypoactive Sexual Desire Disorder, it’s actually been medically characterized for almost 40 years. But I think progress has been remarkably slow because we over simplify.

We love to say, women are complicated. Actually sex is complicated. You know that? Sex is complicated whether I’m a man or woman. I thnk what we needed to do was have a conversation around the biology of sex for women and with all this new and emergent scientific understanding, we’re equipped to do that."

It Isn't "Unnecessary"

In fact, according to Dr. Kingsberg, saying that is like giving women a big slap on the face.

"I think that is the subtle and unconscious sexism that says women’s sexuality doesn’t matter. That it is not something we should be treating. I hear the naysayers, the people who would say that women should be told that it’s just culture sort of pressuring them to be sexual. That’s the problem, it’s not really a condition.

That is so insulting to women! I don’t even know where to begin because we’ve known this as a condition for 35 years now, long before any pharmaceutical company tried to develop a treatment. These women have what is acquired HSDD. They had desire and then they lost it and now they’re distressed by that loss. It’s not a group of women who are just naïve and don’t know that they should be welcoming sex but have no desire. These women themselves say, 'I had it. I lost it. I want it back.'

Why would we deny them that right? Sexual health is a basic human right and we would never assume the fact that men just lost their desire and if they want it back, 'No no, let me just teach you to accept it,' instead of trying to restore it."

If You Suffer From HSDD, Know That You're Not Alone

"[HSDD] is a real condition. We can assess and treat it," Dr. Kingsberg says, "You should talk to your healthcare provider because one of the problems is women suffer in silence because they’re embarrassed to bring it up. They don’t know that it’s something that is an accepted condition. A lot of time, healthcare providers don’t bring it up because they’re also embarrassed or they feel like they have nothing to offer them. [Women] need to make sure they don’t listen to the misdirect that says this is all in your head and therefore you should just lie back and accept it. Try to get better mindfulness that will make you more accepting of your loss of desire opposed to trying to treat it. I think that’s not fair to women. Women deserve treatment and no pun intended, but they shouldn’t take this lying down."

Recent clinical trials found that women who received flibanserin reported to having a 53 percent increase in sexual desire, in comparison to their reported initial baseline score. Additionally, the use of the pink pill doubled the number of satisfying sexual events for the subjects from the time clinical trials began, and women receiving flibanserin reported to having a 29 percent decrease in sexual distress. At the same time, almost 10 percent of the women in the flibanserin group stopped their treatment due to side effects.

Addyi isn't a cure-all drug. The people at Sprout know it, and they want you to know it as well.

"If a relationship is the reason you're not having sex, don't take a pill. That's not going to fix it," Whitehead says. "Doctors can clearly get to the diagnosis of this condition, they’ve been doing it for more than 30 years. It’s not that we can’t diagnose it, there’s just all kinds of resistance to a medical treatment for a medical condition and that’s hard to understand other than to go to the facts that it speaks to condition bias here and I think that’s really unfortunate. But hopefully again, with the conversation having elevated, hopefully we’ll get to meaningful progress for them."

It's Not For Everyone, But It's An Important Step For Women's Health

"It’s not a one size fits all. Not all women will benefit from a drug. Not all women will benefit from Flibanserin." Dr. Kingsberg says, "But certainly, a significant number of women will benefit from Flibanserin, they have benefitted from Flibanserin ... Number one, women deserve treatment options and Flibanserin is an effective treatment that will help thousands of women."

Sprout CEO Whitehead echoes her sentiments.

"You know I look at society as being two of the extremes. It’s either hypersexualized or its totally taboo and we really need to come right down the middle to logic here. Sex is part of who we are. For many of us, it's part of the human experience. If I look at the World Health Organization, they say that sex is a basic human right and I firmly believe that. If you have a medical condition that’s impairing your ability to function in the way that you want sexually, then why wouldn’t you have access to medical treatment options? It will have benefits potentially. It will have risks. But that’s a decision point that needs to be held between women and their healthcare providers."

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Images: Sprout Pharmaceuticals; Giphy(6)