Everything You Always Wanted to Know About Addyi

by Lauren Streicher, MD

by Lauren Streicher, MD

Now that Flibanserin, or Addyi,  — the new drug to treat low libido, or hypoactive sexual desire disorder (HSDD)  is available,  reporters, patients, my friends, and especially my friends’ husbands have peppered me with questions about this so-called “Viagra for women” .

I have no professional experience with Addyi. I do not work for the drug’s manufacturer, Sprout, or have a financial relationship with them. All of my information is based on the results of clinical trials, which are published in the scientific literature and available on the FDA website.

In response to the 25 most-frequently-asked questions that I get, I’ve been telling people:

1. Who should take Addyi (flibanserin)?

This medication is intended for a woman who loves her partner, but whose libido switch is simply in the off, not on, position. Not every woman who has zero sexual desire wants to do something about it. Women with true hypoactive sexual desire disorder are highly motivated to flip their libido switch back on not only for their own pleasure, but often to save a marriage or relationship sabotaged by the absence of normal sexual relations.

2. What causes low sexual desire in women?

The biological cocktail for an intact libido includes not only hormones, but also neurotransmitters.  Dopamine, norepinephrine and serotonin determine how often people think about, and desire, sex. It’s the balance of those neurotransmitters that creates that “I want sex, I need sex, and I’m thinking about sex” feeling. But this balance also keeps desire under control, so you can stop making love long enough to go do all the other things you must. Women with hypoactive sexual desire disorder do not feel normal sexual desire even if they’re in loving relationships. So essentially, this condition is a biological problem.

3. How do I know if I have hypoactive sexual desire disorder?

It’s perfectly normal to not want to have sex with a partner who smells so bad that you don’t even want to share a room. It’s also normal to not desire sex if it’s excruciatingly painful, you just lost your job, or you haven’t slept in a week. If you’re in one of these situations, you don’t need to take a pill. You need to fix your vagina, fix your work situation, and fix your life.

The Decreased Sexual Desire Screener, a five-question, yes-or-no questionnaire  guides both physicians and patients to, or away from, a diagnosis of HSDD.

4. How common is loss of lust?

Of all sexual problems, loss of lust is by far the most common. Up to 1 in 10 adult women are affected by HSDD.

5. How does the new drug work?

Unlike Viagra (sildenafil), which increases blood flow to a man’s penis, Addyi works on a woman’s brain to balance neurotransmitters and restore normal sexual desire.

6. How many women have taken Addyi?

More than 11,000 women participated in the flibanserin clinical trials. In comparison, 3,000 men were in the clinical trials for Viagra. The FDA only requires that clinical trials to approve a new drug involve 1,000 people.

7. What ages were the women who tried the drug?

The trials included for FDA approval included women who had not yet entered menopause who reported that they’d been in loving relationships for a minimum of 10 years, and who’d had HSDD for at least four years.

8. Were all women in the new drug trials heterosexual?

Yes, but sexual function is sexual function. Whether a woman is heterosexual, homosexual, or self-sexual, the biology of sexual desire is the same. There is no reason to believe the response will be any different no matter who (or what) you have sex with.

9. What about women after menopause? Is flibanserin right for them?

The FDA only considered premenopausal women for approval of the drug. However, postmenopausal women with HSDD were included in the Snowdrop trial,  a study of over 900 women with low sexual desire after menopause the results of which were published in the June 2014 issue of Menopause. And it’s good news: The response to flibanserin was statistically significant compared with a placebo treatment.

Doctors will likely prescribe Addyi for postmenopausal women just as many other drugs proven to be effective are prescribed as off-label. If you are postmenopausal, ask your doctor about the pros and cons of taking Addyi.

10. I heard the FDA initially turned down this new “female Viagra.” That worries me.

It should actually reassure you that the FDA is careful and demands a lot of information before approving a drug. In the United States, it usually takes 12-15 years for a proposed drug to appear in your pharmacy. Only 1 in 5,000 new drugs makes the final cut. Along the way, it’s very common for the FDA to require additional studies.

In the case of Addyi, more than 60 studies were submitted to the FDA. One of the side effects in people who took Addyi in clinical trials was sleepiness. In response, the FDA required a driving test to assure that women taking Addyi at night were not drowsy or impaired the next morning. The result? The women who took Addyi actually drove better than the women who did not!

11. Didn’t Sprout, the drug maker, enlist a PR company and use social media to pressure the FDA?

Even the Score is a campaign founded to raise awareness of the need for gender equity in sexual health.  In addition to Sprout,  24 organizations and non-profits and 60,000 people, support the campaign. But Even the Score isn’t just about one drug: The campaign will continue to address the disparity between research in male and female sexual health. Yes, it was Even the Score that was responsible for the spoof on Viagra commercial.

Remember: For approval, the FDA requires that a drug must both meet an unmet need, and be deemed effective and safe. The FDA approved Addyi because the science is solid, and it demonstrated these criteria. The FDA reviews data, not Tweets.

12. How well does Addyi work?

Women who took flibanserin in clinical trials reported a 53 percent increase in their sexual desire as measured by the Female Sexual Function Index (FSFI). They also reported that their number of satisfying sexual events doubled, and their distress about sexual function decreased by 29 percent.

13. Were the improvements only “modest” for most women?

Modest was the goal. The idea is not to make women hypersexual, but rather to give them normal sexual desire.

Results are an average. They include both people who didn’t respond to the drug, because not everyone is going to benefit from the drug, and “high responders.” The high responders reported six to eight more satisfying sexual events each month, and a return of their sexual desire score to what’s considered normal. That’s meaningful!

14. So how likely is Addyi to work?

There was an average of 53 percent increase in sexual desire overall, but 55 percent of women were high responders and had an even greater response.

15. How soon will it work?

Flibanserin usually starts to show positive effects two to four weeks after a woman begins taking the drug. If you see no difference in two or three months, stop taking Addyi. It’s not going to help you.

16. Why take a pill? What’s wrong with talk therapy?

Sexual problems from interpersonal, psychological, or cultural/social issues are important, and a therapist or change of relationship is often the fix. But brain activity is different in women who have HSDD: No amount of talk therapy is going to correct a biological imbalance. On the other hand, if you hate your partner or you avoid sex because it hurts like hell, a bucket full of Addyi is not going to make a difference, either.

17. Can Addyi make a woman too sexual?

It’s interesting how, on one hand, people are concerned that it doesn’t work well enough, and on the other hand, people are worried that it will turn women into nymphomaniacs. The ideal is to be normal, not hypersexual. Addyi will not cause you to rip off your clothes during a business meeting and seduce your boss any more than an antidepressant will make you euphoric.

18. Does this drug pose a potential “date rape” risk?

No, this is a daily drug that does not start to work for a couple of weeks. Even if your partner sneaks a dose into your morning coffee every day for two weeks, it wouldn’t make you hypersexual or make you do things you did not want to do.

19. Is Addyi a hormone?

No. It’s a new drug that modulates (controls) neurotransmitters like dopamine, norepinephrine, and serotonin that affect women’s desire for sex.

20. I’ve heard about side effects. What are they?

Typically, the most common side effects of a sexual dysfunction drug are cardiovascular problems, visual changes, a drop in blood pressure, or an erection that lasts for more than four hours.

Whoops, that would be Viagra!

Back to Addyi: the most common side effects in the trials included fatigue, nausea, and sleepiness. No serious side effects were reported. The biggest complaint from participants was that when the trial was over, they couldn’t keep taking it. Every drug comes with some risks, though; men have long been able to choose whether to take a drug with known risks to enhance sexual desire.

21. Will Addyi cause weight gain?

No, it did not cause weight gain in the clinical trials.

22. What about interactions between alcohol and flibanserin?

Drinking was allowed in the studies for this new drug, and the women in the clinical trial who identified as “social drinkers” (58 percent of the participants) did not have any significant issues.

The FDA was particularly concerned about binge drinking, so they required an alcohol challenge test to reproduce what heavy drinkers would experience if they were on Addyi. Some of the participants in that study had a drop in blood pressure or passed out.

Interactions with alcohol need to be discussed just as they would with any drug that affects your central nervous system. All centrally-acting drugs (think antihistamines, antidepressants, and hundreds of other drugs) are known to interact with alcohol, and the FDA requires a similar warning for these.

23. I hear that only men were included in the alcohol study. What about women?

The social drinkers in the study were women. However, the “alcohol challenge study” required participants to drink a half-bottle of grain alcohol first thing in the morning. They couldn’t get enough women to agree to the study, so they got permission from the FDA to do the test with men.

24. So does that mean that if I take Addyi, I can never have a glass of wine?

 Remember that 58 percent of women in the clinical trial identified as “social drinkers” and did not have any significant issues. The FDA however is very concerned about a potential alcohol interaction and is requiring physicians to advise their patients to not drink if they take Addyi. Hopefully as more information and experience comes out they will back off on this warning.

25. When and where can I get flibanserin?

 Flibanserin is available now but you must make an appointment with a physician that is a certified prescriber and get it from a pharmacist that has also been certified. Interesting that the FDA does not require doctors and pharmacists to be certified to prescribe and dispense Viagra, anti-depressants, narcotics or hundreds of other drugs that have significantly greater risks and side effects. Some might call that sexist. Just saying.

EDH Aug 2015