On Dec. 15, Sprout Pharmaceuticals received approval to use its pill, Addyi (flibanserin), to treat low sexual desire in women who are past menopause.
Addyi works by addressing neurotransmitters like dopamine, norepinephrine, and serotonin in the brain, balancing them to stimulate sexual desire signals while suppressing inhibitory ones. The pill has been approved by the U.S. Food and Drug Administration (FDA) since 2015 to treat hypoactive sexual desire disorder (HSDD) in pre-menopausal women, and the expanded approval includes women under age 65 who are past menopause, a time when hormone levels drop and libido changes.
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The FDA required Sprout to conduct additional tests on women after menopause to ensure the drug’s safety and efficacy in the larger age group—a requirement that Cindy Eckert, Sprout’s CEO, says represents a double standard and stigma against addressing sexual desire in women. Eckert discussed with TIME the company’s long road to the approval and the larger issues facing certain medicines for women.
This interview has been condensed and edited for clarity.
What does finally receiving FDA approval for Addyi in post-menopausal women mean for women’s health?
I might not have fully processed yet how big this win is. It’s an historic first in women’s health. I think this signifies not only scientific recognition of a medical condition that affects millions of women that had been previously discussed only with stigma, not science, but also a cultural recognition that we value sexual health as part of women’s overall wellness, their longevity, and their well-being. And that their sex life doesn’t end at menopause. To me, we played the long game, and culture caught up.
Why did Sprout have to file a separate request to treat decreased libido in women past menopause?
I built a male sexual health company at a time when there was only long-acting testosterone treatment for men. Now there are 26 FDA-approved treatments for some form of male sexual dysfunction, but there were none for women. I watched the big guns not do anything about the science, and that was a commentary on the perspective they had on women’s health: they don’t value sexual health in women the same as they do in men. We left women out of the conversation.
So Sprout took it on. And I should have anticipated that the first-ever drug for women’s sexual pleasure would not follow a straight line. To me, it’s about the science. HSDD was characterized in 1977. Medicine has understood it for some time now, but what crept in was social commentary, a societal bias that questions whether pleasure matters for women.
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In the end, Addyi was approved [in 2015 for pre-menopausal women] on the basis of science, with clinical trials involving 13,000 women, which was three times the size of the trials conducted on Viagra at the time of its [FDA] submission. Granted, erectile dysfunction is different from HSDD in women, but the FDA took six months to approve Viagra, and by contrast it took us six years to earn approval for Addyi.
Addyi works on neurotransmitters in the brain. If you think of other drugs that work in the central nervous system, we don’t separate populations by age in the same way. But that was the FDA mandate. It’s the same molecule, and the same dosage as Addyi that was approved for HSDD. But there is a pattern in women’s health where we lead with a skewed point of view on the importance of factors—including the desire for sex—that are societally conditioned. The world wasn’t ready for a female Viagra.
Why did it take so long to earn FDA approval for Addyi in the first place?
Not only do we rule out anything a woman is experiencing as probably emotional and not medical, if there is a medical solution, we lead with its risk. The reason for that is that we have already dismissed that there is any benefit in addressing her symptoms.
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When Addyi first came out, there were discussions about the risks when taken with alcohol. Studies showed that some women experienced side effects including dizziness, sleepiness and nausea, and less than 2% had to discontinue Addyi because of them. So if you have one or two drinks in the evening, wait a couple of hours before taking Addyi at bedtime. Or if you have more than three drinks, then skip Addyi that night. It’s common sense.
We [as a society] talk about the risks of Addyi and alcohol in every article. But it’s not our call, it’s every woman’s call. She gets to weigh the benefits—more desire for sex, more interest in sex, more satisfying sexual events, and less stress over her condition.
What challenges have you faced in bringing a pill for women in menopause to market?
More women experience sexual dysfunction than men globally. The expansion to post-menopausal women is long overdue. As a female founder in health, even when raising money for this product that has a higher prevalence than erectile dysfunction, we weren’t getting any money from Sand Hill Road [a part of Silicon Valley rife with venture capitalists].
I had built a successful company in men’s sexual health. I had seen what the standard was there. When the same standard wasn’t applied for women, I questioned it and pushed back. I had a six-hour, very public conversation with the FDA about this, and there was a lot of manufactured controversy—because of how we feel about women and sex.
Why do you think sexual desire in women is not treated seriously by the medical community?
The fact is that 50% of the population goes through menopause, and we’re told, “Just relax, take a bubble bath; it’s just a transition period.” It’s literally a biological phenomenon, and we treat it by telling people to just calm down.
There’s a concept in medicine that women’s symptoms are considered more likely to be psychosomatic and more likely based in emotions. It shows up in the way we treat women’s heart attacks, and that it takes longer to prescribe pain medication for women than for men.
To me, the basis of that is that we believe women are entirely psychological creatures rooted in emotion, while men are biological creatures. That gives us as a society extraordinary permission to dismiss what women are experiencing, because once we decide that women are emotional, any symptom women report, they’re patted on the shoulder and told to relax. We’ve created a culture of dismissal.
What does this approval mean for other women’s health products?
To me, this is a litmus test for what this conversation is going to be like. Now we are saying half of the population goes through this thing called menopause. Now we are taking it, I hope, a little more seriously. It will be fascinating if this conversation is fundamentally different this time around. Addyi is a case study for whether things have actually changed.
Finally, Addyi is a pink pill, and you often dress in pink. How did that start?
Pink is a bit of active defiance to me. When people were patting me on the shoulder, saying, ‘Oh the little pink pill,’ I recognized that in that was dismissiveness and trivialization, and that was the very conversation I wanted to have: you perceive [women’s loss of sexual desire] as weakness or unimportant, but I see it very differently. I was criticized for wearing pink and was told people wouldn’t take me seriously. But I believe you always get two choices. You either lean back away from it and distance yourself, or you lean right in toward it. I always loved pink, and never saw it as a sign of weakness. I see it as a strength to show up exactly as you are.
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