December 15 Sprout Pharmaceuticals received approval use Addyi tablet (flibanserin) to treat low sex drive in women who have gone through menopause.
Addyi works by affecting neurotransmitters such as 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 US Food and Drug Administration (FDA) since 2015 to treat hypoactive sexual desire disorder (HSDD) in premenopausal women, with expanded approval to include women under 65 years of age who have gone through menopause. menopausea time when hormone levels drop and libido changes.
The FDA required additional analysis of data on postmenopausal women to ensure the drug's safety and effectiveness in a broader age group. This requirement, according to Cindy Eckert, CEO of Sprout, represents a double standard and stigma for addressing women's sexual desire, since the data was part of the company's original application for approval and included women from 18 to 80 years old. Eckert spoke with TIME about the company's long road to approval and the larger challenges facing some drugs for women.
This interview has been condensed and edited for clarity.
What does finally receiving FDA approval for Addyi for postmenopausal women mean for women's health?
Perhaps I have not yet fully realized how big this gain is. This is a historic event in the field of women's health. I think this means not only scientific recognition of a condition that affects millions of women, which was previously only discussed with stigma rather than scientific insight, but also cultural recognition that we value sexual health as part of women's overall health, longevity and well-being. And that their sex life does not end with menopause. In my opinion, we played the long game and the culture caught up with us.
Why did Sprout have to submit a separate request for treatment for decreased libido in women after menopause?
I started a men's sexual health company at a time when there was only long-acting testosterone for men. There are now 26 FDA-approved treatments for some form of sexual dysfunction in men, but none for women. I watched the big guns do nothing with the science, and it was a commentary on their view of women's health: they don't value women's sexual health as much as men. We have left women out of the conversation.
So Sprout took it on. And I should have known that the world's first drug for female sexual pleasure would not follow a straight line. For me it's science. HSDD was characterized in 1977. Medicine has long understood this, but social commentary has crept in, a social prejudice that questions whether pleasure matters to women.
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In the end, Addy was approved. [in 2015 for pre-menopausal women] based on science, with clinical trials involving 13,000 women, which is three times the volume of trials conducted on Viagra when it was introduced. [FDA] subordination. Of course, erectile dysfunction in women is different from HSDD, but it took the FDA six months to approve Viagra while it took us six years to get approval for Addyi.
Addie works with neurotransmitters in the brain. If you think about other drugs that act on the central nervous system, we don't stratify the population by age in the same way. But that was an FDA mandate. This is the same molecule and dosage as Addyi, which is approved to treat HSDD. But there is a tendency in women's health to take a skewed view of the importance of factors, including the desire for sex, that are conditioned by society. The world was not ready for female Viagra.
Why did it take so long to get FDA approval for Addyi?
Not only do we rule out anything a woman experiences as possibly being emotional rather than medical, but if there is a medical solution, we take the risk of it. The reason is that we have already rejected the idea of any benefit from treating her symptoms.
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When Addie was first born, there was discussion about the risks associated with drinking alcohol. Studies have shown that some women experienced side effects including dizziness, drowsiness, and nausea, and less than 2% of them had to stop taking Addyi because of them. So if you have one or two drinks in the evening, wait a couple of hours before taking Addyi before bed. Or, if you've had more than three drinks, skip the Addie that night. This is common sense.
We [as a society] talk about the risks of Addyi and alcohol in every article. But this is not our calling, this is the calling of every woman. She will have to weigh all the benefits: more desire for sex, more interest in sex, more satisfying sexual experiences, and less stress about her condition.
What challenges did you face in bringing a pill for menopausal women to market?
Worldwide, more women suffer from sexual dysfunction than men. Expanding coverage of postmenopausal women is long overdue. As a female healthcare founder, even when we were raising money for this product, which has a higher prevalence than erectile dysfunction, we did not receive any money from Sand Hill Road. [a part of Silicon Valley rife with venture capitalists].
I built a successful company in the field of male sexual health. I saw what the standard is there. When the same standard was not applied to women, I questioned it and spoke out against it. I had a six-hour public conversation with the FDA about this, and there was a lot of fabricated controversy about how we treat women and sex.
Why do you think the medical community doesn't take women's sexual desire seriously?
The fact is that 50% of the population is going through menopause, and we are told: “Just relax, take a bubble bath; This is just a transition period.” It's literally a biological phenomenon, and we treat it by telling people to just calm down..
There is a concept in medicine that women's symptoms are more often considered psychosomatic and based on emotions. This is reflected in the way we treat women's heart attacks: women take longer to be prescribed painkillers than men.
In my opinion, the basis of this is that we believe that women are completely psychological beings based on emotions, and men are biological beings. This gives us as a society the exclusive right to ignore what women experience because as soon as we decide that women are emotional, any symptoms women report, they are patted on the shoulder and told to relax. We have created a culture of dismissal.
What does this approval mean for other women's health products?
For me, this is the litmus test of what this conversation will be like. Now we say that half the population is going through what is called menopause. Now we take it, I hope, a little more seriously. It will be interesting if this conversation is fundamentally different this time. Addyi is an example of whether things have really changed.
Finally, Addyi is the pink pill and you often dress in pink. How did it start?
To me, pink represents a kind of active defiance. When people tapped me on the shoulder and said, “Oh, that little pink pill,” I knew it was dismissive and trivial, and that was exactly the conversation I wanted to have: you know. [women’s loss of sexual desire] as weakness or unimportance, but I see it completely differently. I was criticized for wearing pink and told that people wouldn't take me seriously. But I believe you always have two options. You either lean away from him and move away, or you lean right into him. I have always loved the color pink and never considered it a sign of weakness. I see the power in this – to show up exactly as you are.
Correction, December 16.
The original version of this story incorrectly described how the drug was approved for postmenopausal women. The FDA required further review of the data Sprout had already provided; no new studies were conducted.
