The FDA Approval Journey of Addyi

It was rejected by the Food and Drug Administration twice — and when

INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

The documentary — helmed by acclaimed director Aisling Chin-Yee (No Ordinary Man, Rest of Us, Plan B) — explores the inherent gender bias in women's health through stories of real women who restored their libido by using a little pink pill, Addyi. Addyi is an FDA-approved, non-hormonal prescription medication that’s been mistakenly called “female Viagra.” But unlike that little blue pill, Addyi works in the brain, not the body — and instead of taking it before sexual activity, it’s meant to be taken daily to increase sexual desire in perimenopausal and menopausal women. “I feel like a new woman on this drug,” one woman who took the pill shares in the documentary’s trailer. But the road to approval wasn’t easy. It took entrepreneur Cindy Eckert, founder of Sprout Pharmaceuticals, which manufactures the drug, 10 years to get the green light. it was approved, it had a black box warning, which has since been removed.

Product	Dosage	Quantity + Bonus	Price
Cialis Original	20mg	92 + 4 Pills	377.99€ 359.99€	Buy
Viagra Generic	50mg	360 + 10 Pills	225.33€ 214.60€	Buy
Apcalis SX Oral Jelly	20mg	50 + 6 Sachets	146.39€ 139.42€	Buy
Viagra Generic	200mg	10 Pills	40.96€ 39.01€	Buy
Cialis Black	80mg	360 + 20 Pills	639.78€ 609.31€	Buy
Viagra Generic	200mg	360 + 10 Pills	481.98€ 459.03€	Buy
Kamagra Soft Tabs	100mg	12 Pills	57.55€ 54.81€	Buy
Cialis Generic	20mg	180 + 10 Pills	254.09€ 241.99€	Buy
Kamagra Oral Jelly	100 mg	63 + 7 Sachets	224.18€ 213.50€	Buy
Viagra Soft Tabs	100mg	90 + 6 Pills	205.31€ 195.53€	Buy
Levitra Soft Tabs	20mg	120 + 8 Pills	288.52€ 274.78€	Buy
Levitra Original	20mg	64 + 4 Pills	298.45€ 284.24€	Buy
Cialis Soft Tabs	20mg	180 + 8 Pills	353.17€ 336.35€	Buy

The film examines the systemic bias against women’s care, including

Related Stories

I see it as a strength to show up exactly as you are. The original version of this story mischaracterized how the drug was approved for post-menopausal women. The FDA required an additional review of data Sprout had already provided; new studies were not conducted. The new documentary, The Pink Pill: Sex, Drugs and Who Has Control, looks at the decade-long fight to bring a pill for women's sexual health to market Addyi is a pill that can improve a woman’s libido, but concerns that women would “not make good choices” on it delayed its approval The documentary explores systemic gender inequalities that work against women's sexual health It’s a small pink pill that can help women regain control of their sexual health. That’s the question explored in the new documentary, The Pink Pill: Sex, Drugs and Who Has Control. concerns that women would “not make good choices” on the medication. There haven’t been, at least publicly, similar concerns about medications for male erectile dysfunction.

Episode Transcript

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. “How do you take on the government for women's sexual pleasure?” Eckert says in the trailer.

• Pink pills are sometimes associated with the "pink economy" in sexual health.
• They are popular among women seeking discreet, quick solutions.
• Not all pink pills are evidence-based; some rely heavily on marketing claims.
• Consulting a healthcare professional is essential before starting any supplement.

“You lean right into it and say, ‘This is the conversation we're going to

Warnings & Precautions

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. 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.

Missed Dose

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. 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. 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.

As Seen In

Read More: What to Know About Early Menopause 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. It’s the same molecule, and the same dosage as Addyi that was approved for HSDD. have.'” The Pink Pill: Sex, Drugs and Who Has Control is now streaming through DOCNYC.

• Some pink pills contain ingredients like L-arginine to stimulate blood flow.
• They're sometimes recommended alongside other fertility or health treatments.
• The branding and marketing are often targeted towards women seeking empowerment.
• Quality control can vary significantly between brands and products.

The Food and Drug Administration’s recent approval of a marginally effective drug to

What women are saying

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. 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. Read More: How to Fight Hair Loss During Menopause When Addyi first came out, there were discussions about the risks when taken with alcohol.

How does Addyi work (mechanism of action)?

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. 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.

What are the most common side effects of Addyi?

She gets to weigh the benefits—more desire for sex, more interest in sex, more satisfying sexual events, and less stress over her condition. 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. enhance the sexual drive of women with low libido raises a lot of questions.

Find out if treatment is right for you.

I’ve shared it with so many people since you first told me about it two years ago at SXSW. So inspiring to see how far it’s come — and I know this is just the beginning. I was awe struck meeting you 7 yrs ago and still am. Thank you for your genius, bravery and perseverance. Women need people like you who stick up for what's right and uncomfortable.

Drug information

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.

IN CLINICAL TRIALS1, WOMEN ON ADDYI EXPERIENCED:

The FDA required an additional review of data 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, since that data was part of the company's original submission for approval and included women 18 to 80 years old. 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. I might not have fully processed yet how big this win is. It’s an historic first in women’s health. We will probably never know whether the agency made a purely scientific

The research behind the “pink pill”

I had seen what the standard was there. When the same standard cenforce 100mg tablet 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. 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.

Ask her, and start the conversation.

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. To me, this is a litmus test for what this conversation is going to be like.

Is Lack of Desire all in Our Heads??

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. Pink is a bit of active defiance to me. judgment or whether a campaign called “Even the Score” unduly influenced it.

Aspect	Description	Usage Frequency	Intended Benefits
What is the Pink Pill	A supplement or medication aimed at improving women's health	Daily, Weekly, As prescribed	Enhances mood, energy, libido
Main Ingredients	Melatonin, herbal extracts, vitamins	varies	hormonal balance, vitality
Target Audience	Women aged 25-50	N/A	Women's health improvement

This campaign was partly financed by the manufacturer and organized with the help of one of its consultants.

• The popularity of pink pills reflects increasing openness about female sexuality.
• They may also contain vitamins and minerals for overall reproductive health.
• Effectiveness depends on individual health conditions and underlying issues.
• Some formulations are designed for specific age groups or hormonal states.