The FDA Approval Journey of Addyi

She’s worried about it, she’s frustrated.” According to the International Journal of Women’s Health, as many as 1 in 10 women suffer from HSDD.

Side Effects

“They came from all walks of life, but every person’s story at some point was exactly the same,” she recalls. This is the same struggle.” Despite being in happy relationships, these women had little to no sexual desire. When they were intimate with their partners, it often took the form of “mercy sex,” because they loved their partner and wanted them to feel pleasure, even though the women weren’t experiencing any themselves. The worst part: They didn’t know why they felt this way—and all of the so-called solutions (date nights, relaxing bubble baths, etc.) didn’t work. Those real-talk conversations were Cindy’s secret fuel as she sold Slate Pharmaceuticals, founded Sprout Pharmaceuticals, and began the grueling six-year FDA approval process for Addyi, the first medication designed to treat HSDD in premenopausal women. While many doctors agree HSDD is a problem that should be addressed, there are no medical treatment options. Whitehead believes Flibanserin is the solution to solving female sexual dysfunction, but said it’s not accurate to call the drug “female Viagra” because it doesn’t work in the same way that Viagra does for men. “Viagra is a blood-flow issue, a mechanical issue, and Flibanserin works on key chemicals in the brain,” she said. Scientists have known for years that a woman’s most significant sexual organ is actually her brain, which is what makes female desire disorders so hard to treat. Flibanserin is taken daily at bedtime, but it’s not a hormonal supplement. Instead, the pill manipulates certain chemicals in the brain to achieve desire.

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To test it in clinical trials, Whitehead said it was important to find women who genuinely suffer from HSDD, and not just boredom. “There's a diagnostic questionnaire that physicians go through, and they really can pretty quickly get to whether or not this is a relationship dynamic or something that's happening biologically,” she said. Amanda Parrish said that’s exactly what she was facing. A mother of four from Nashville, Tenn., Parrish said she used to have a smoldering sex life with her husband, but over time, things cooled off. She said the problem wasn’t with him, but with her. “I felt like even though we were close and having a great relationship there was something that wasn't extremely gratifying,” Parrish said. “There was something just not there, so I was in search of something that would make that happen.” Feeling pressure to be a so-called “wholesome soccer mom,” Parrish said she never discussed the issue with her friends but had a feeling she wasn’t alone. A David and Goliath battle to win FDA approval for a drug that boosts a woman’s sexual desire, much as Viagra helps men overcome erectile dysfunction, is captured in the trailer for Aisling Chin-Yee’s documentary The Pink Pill: Sex, Drugs & Who Has Control, which dropped on Thursday.

Overdose/Missed Dose

The proof was in the pictures: Women with the condition had very little to no activation in the pleasure centers of the brain compared to women with normal desire. “Here it was in black-and-white, but everyone sat there looking at their phones,” Cindy says. She glanced around at the group and wondered, Well, who’s doing something about this? As the old adage goes, if you want something done right—or, in the case of women’s sexual health, at all—you gotta do it yourself. A self-proclaimed science nerd, Cindy was drawn to the field of sexual health because it was a relatively new concept, ripe for discovery.

Common side effects

Despite the “taboo” nature of her work, she loved that the findings made a real difference in people’s lives. “From the moment I stepped into the male sexual health space, my fascination was: This matters in someone’s overall life experience,” she says. “Sex is an integral part of the human experience, and when you can improve that for somebody, it’s the highest reward.” But seeing those images at the conference—and realizing that no one else seemed to care—spurred Cindy to ask the “obvious,” she says: How can we have as many as 26 FDA-approved medications for men to lead a more satisfying sex life and not a single one for women? “I knew, based on the data, more women than men actually struggle” with sexual dysfunction. About half of women—40 to 50 percent—will, at some point in their life, suffer from at least one of the four main types of sexual dysfunction: desire disorders, arousal disorders, orgasm disorders, and pain disorders.

The Evidence Is Underwhelming at Best

The most prevalent is HSDD, affecting about 10 percent of women, predominantly those age 45 and older. In fact, nearly 42 percent of women report a drop in sexual desire during perimenopause. Meanwhile, erectile dysfunction—the main type of sexual dysfunction in men—affects up to 14 percent of men under age 40, increasing to about 52 percent between ages 40 and 70. For Cindy, the issue was also personal. She’d struggled with symptoms of HSDD, as well as with the (lack of) treatment options. “How do you take on the government for women’s sexual pleasure? You lean right into it and say, ‘This is the conversation we’re going to have,’” says Cindy Eckert, whose Sprout Pharmaceuticals fought a campaign to bring to market Addyi, dubbed “female Viagra” by the media, at one point in the teaser. For her efforts, Eckert faced regulatory roadblocks, restrictions and public attacks. The Pink Pill, produced by Julie Bristow of Catalyst and Abby Greensfelder of Everywoman Studios, will have a world premiere at DOC NYC on Nov. 15. Before that, Sphere Abacus, handling global sales, will shop the film to U.S. and other international buyers at MIPCOM next week. And Paramount+ will release the documentary in Canada in early 2026. Eckert’s ultimate victory in securing regulatory approval for Addyi underpins the documentary’s revelations about gender bias at the FDA as a drug that claimed to improve female pleasure was dismissed as trivial or even dangerous. “I am thankful for the trust that I was given by the people I spoke to in the making of this film, and proud to spotlight those who challenge the inequity and systemic bias against women’s and marginalized bodies’ needs, especially in something as fundamental as sexual health,” Chin-Yee said in a statement as she hopes her film sparks a wider conversation about a more equitable healthcare system.

• The pink pill aims to boost women's libido and sexual satisfaction.
• It often contains ingredients like aphrodisiacs or hormonal components.
• Some pink pills are marketed as supplements; others are pharmaceutical drugs.
• Effectiveness varies; consult a healthcare provider before use.

The film is executive produced by Bristow, Greensfelder, Chin-Yee, Vibika Bianchi and Knix founder and president Joanna Griffiths, a backer of Docs for Change, a collaboration between Catalyst, the Toronto-based studio, and Knix Fund, the charity arm of the Knix brand.

What does finally receiving FDA approval for Addyi in post-menopausal women mean for women’s health?

She’s worried about it, she’s frustrated.” According to the International Journal of Women’s Health, as many as 1 in 10 women suffer from HSDD. While many doctors agree HSDD is a problem that should be addressed, there are no medical treatment options. Whitehead believes Flibanserin is the solution to solving female sexual dysfunction, but said it’s not accurate to call the drug “female Viagra” because it doesn’t work in the same way that Viagra does for men. “Viagra is a blood-flow issue, a mechanical issue, and Flibanserin works on key chemicals in the brain,” she said. Scientists have known for years that a woman’s most significant sexual organ is actually her brain, which is what makes female desire disorders so hard to treat.

Missed Dose

Flibanserin is taken daily at bedtime, but it’s not a hormonal supplement. Instead, the pill manipulates certain chemicals in the brain to achieve desire. To test it in clinical trials, Whitehead said it was important to find women who genuinely suffer from HSDD, and not just boredom. “There's a diagnostic questionnaire that physicians go through, and they really can pretty quickly get to whether or not this is a relationship dynamic or something that's happening biologically,” she said. Amanda Parrish said that’s exactly what she was facing.

Drug Interactions

A mother of four from Nashville, Tenn., Parrish said she used to have a smoldering sex life with her husband, but over time, things cooled off. She said the problem wasn’t with him, but with her. “I felt like even though we were close and having a great relationship there was something that wasn't extremely gratifying,” Parrish said. “There was something just not there, so I was in search of something that would make that happen.” Feeling pressure to be a so-called “wholesome soccer mom,” Parrish said she never discussed the issue with her friends but had a feeling she wasn’t alone. A David and Goliath battle to win FDA approval for a drug that boosts a woman’s sexual desire, much as Viagra helps men overcome erectile dysfunction, is captured in the trailer for Aisling Chin-Yee’s documentary The Pink Pill: Sex, Drugs & Who Has Control, which dropped on Thursday. Sign up for THR news straight to your fildena 150 mg tablet inbox every day Just days after the U.S. Food and Drug Administration approved Addyi — the first prescription drug designed to boost sexual desire in women — Canadian company Valeant Pharmaceuticals announced they would be purchasing drug’s maker, Sprout Pharmaceuticals, for $1 billion. Valeant said that they expect the drug to be available in the United States sometime in the fourth quarter of 2015.

See also:

“Here I was, running a company for men to lead more satisfying sex lives and missing out on having one of my own,” she says. “I wanted that part of myself back, but I was dismissed when I brought up the concern to my ob-gyn.” She was told it was a psychological problem and the solution was to light candles, practice mindfulness—just relax. HSDD took a toll on her relationship, which ended, and on her self-confidence as well. “I’d accepted that dim reality,” she says. But when she saw the numbers and the science on that screen, “lightning struck.” Cindy spent the next year working with the “best sexual medicine doctors in the world” and listening to female patients share their experiences. The drug is being marketed as the “female viagra” however the two drugs couldn’t be more different. The search for a pill to treat women’s sexual difficulties was pursued and later abandoned by Pfizer, Bayer, and Procter & Gamble, among others.

Find out if treatment is right for you.

The search for a pill to treat women’s sexual difficulties was pursued and later abandoned by Pfizer, Bayer, and Procter & Gamble, among others. But drugs that act on blood flow, hormones, and other biological functions all proved ineffective. Addyi, known generically as flibanserin, is intended to treat women who report emotional stress due to a lack of libido. It’s the first drug that acts on brain chemicals that affect mood and appetite. In comparison, Viagra works by increasing blood flow, relaxing muscles in the penis to allow for a man who is already aroused to experience an erection.

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Addyi and Viagra, a side-by-side comparison: The FDA previously rejected Addyi in 2010 and 2013, due to lackluster effectiveness and side effects which can include dangerously low blood pressure and fainting, especially when combined with alcohol. The same problems can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections. Opponents say it’s not worth the side effects. However Even the Score, a lobbying group funded by Sprout and other pharmaceutical companies, began publicizing the lack of drugs for female sexual dysfunction as a women’s rights issue last year. At an FDA meeting in June, more than 30 people called for the drug’s approval, frequently citing the campaign.

Drug information

They vastly outnumbered speakers who spoke in opposition to the drug. Story by CCTV America and the Associated Press. Cindy Eckert first learned about hypoactive sexual desire disorder (HSDD)—the most common type of sexual dysfunction in women—while attending a conference as a cofounder of Slate Pharmaceuticals, a male-hormone company. (At the time, Slate’s main drug was a testosterone treatment.) During a presentation, scientists showed brain scan images comparing how women with pink pills for woman normal desire and women with HSDD reacted to erotic materials. The condition is described by the American Sexual Health Association as “the absence of sexual fantasies and thoughts, and/or desire for or receptivity to, sexual activity that causes the person distress or difficulties.” Cindy compares HSDD to a light switch in the brain that can essentially shut off libido. But drugs that act on blood flow, hormones, and other biological functions all proved ineffective. Addyi, known generically as flibanserin, is intended to treat women who report emotional stress due to a lack of libido. It’s the first drug that acts on brain chemicals that affect mood and appetite.

Country	Approval Status	Key Brands Available	Price Range ($)
USA	Not FDA-approved, available as supplement	PinkVibe, FemaleGlow	10-30 per bottle
UK	Dietary supplement, no specific regulation	HarmonyPink, FeminaCare	8-25 per bottle
Australia	Approved as dietary supplement	LadyBoost, PinkPower	12-35 per bottle
Canada	Approved as supplement	FemmeVital, Women's Health Plus	15-40 per bottle

In comparison, Viagra works by increasing blood flow, relaxing muscles in the penis to allow for a man who is already aroused to experience an erection. Addyi and Viagra, a side-by-side comparison: The FDA previously rejected Addyi in 2010 and 2013, due to lackluster effectiveness and side effects which can include dangerously low blood pressure and fainting, especially when combined with alcohol. The same problems can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections. Opponents say it’s not worth the side effects. However Even the Score, a lobbying group funded by Sprout and other pharmaceutical companies, began publicizing the lack of drugs for female sexual dysfunction as a women’s rights issue last year. At an FDA meeting in June, more than 30 people called for the drug’s approval, frequently citing the campaign. They vastly outnumbered speakers who spoke in opposition to the drug. Story by CCTV America and the Associated Press. Cindy Eckert first learned about hypoactive sexual desire disorder (HSDD)—the most common type of sexual dysfunction in women—while attending a conference as a cofounder of Slate Pharmaceuticals, a male-hormone company. (At the time, Slate’s main drug was a testosterone treatment.) During a presentation, scientists showed brain scan images comparing how women with pink pills for woman normal desire and women with HSDD reacted to erotic materials. The condition is described by the American Sexual Health Association as “the absence of sexual fantasies and thoughts, and/or desire for or receptivity to, sexual activity that causes the person distress or difficulties.” Cindy compares HSDD to a light switch in the brain that can essentially shut off libido. The proof was in the pictures: Women with the condition had very little to no activation in the pleasure centers of the brain compared to women with normal desire. “Here it was in black-and-white, but everyone sat there looking at their phones,” Cindy says. She glanced around at the group and wondered, Well, who’s doing something about this? As the old adage goes, if you want something done right—or, in the case of women’s sexual health, at all—you gotta do it yourself. A self-proclaimed science nerd, Cindy was drawn to the field of sexual health because it was a relatively new concept, ripe for discovery. Despite the “taboo” nature of her work, she loved that the findings made a real difference in people’s lives.

• The pink pill targets issues like low desire and menstrual discomfort.
• It may improve mood and increase energy levels in women.
• Side effects can include headaches, nausea, or hormonal imbalances.
• Its use is often personalized based on hormonal levels and health status.

“From the moment I stepped into the male sexual health space, my fascination was: This matters in someone’s overall life experience,” she says. “Sex is an integral part of the human experience, and when you can improve that for somebody, it’s the highest reward.” But seeing those images at the conference—and realizing that no one else seemed to care—spurred Cindy to ask the “obvious,” she says: How can we have as many as 26 FDA-approved medications for men to lead a more satisfying sex life and not a single one for women? “I knew, based on the data, more women than men actually struggle” with sexual dysfunction.

Addyi is the #1 Prescribed Treatment for HSDD.1

About half of women—40 to 50 percent—will, at some point in their life, suffer from at least one of the four main types of sexual dysfunction: desire disorders, arousal disorders, orgasm disorders, and pain disorders. The most prevalent is HSDD, affecting about 10 percent of women, predominantly those age 45 and older. In fact, nearly 42 percent of women report a drop in sexual desire during perimenopause. Meanwhile, erectile dysfunction—the main type of sexual dysfunction in men—affects up to 14 percent of men under age 40, increasing to about 52 percent between ages 40 and 70. For Cindy, the issue was also personal. She’d struggled with symptoms of HSDD, as well as with the (lack of) treatment options. “Here I was, running a company for men to lead more satisfying sex lives and missing out on having one of my own,” she says. “I wanted that part of myself back, but I was dismissed when I brought up the concern to my ob-gyn.” She was told it was a psychological problem and the solution was to light candles, practice mindfulness—just relax. HSDD took a toll on her relationship, which ended, and on her self-confidence as well. “I’d accepted that dim reality,” she says.

The Clinically Proven Treatment for Low Sexual Desire

“How do you take on the government for women’s sexual pleasure? You lean right into it and say, ‘This is the conversation we’re going to have,’” says Cindy Eckert, whose Sprout Pharmaceuticals fought a campaign to bring to market Addyi, dubbed “female Viagra” by the media, at one point in the teaser. For her efforts, Eckert faced regulatory roadblocks, restrictions and public attacks. The Pink Pill, produced by Julie Bristow of Catalyst and Abby Greensfelder of Everywoman Studios, will have a world premiere at DOC NYC on Nov. 15.

Related support groups

Before that, Sphere Abacus, handling global sales, will shop the film to U.S. and other international buyers at MIPCOM next week. And Paramount+ will release the documentary in Canada in early 2026. Eckert’s ultimate victory in securing regulatory approval for Addyi underpins the documentary’s revelations about gender bias at the FDA as a drug that claimed to improve female pleasure was dismissed as trivial or even dangerous. “I am thankful for the trust that I was given by the people I spoke to in the making of this film, and proud to spotlight those who challenge the inequity and systemic bias against women’s and marginalized bodies’ needs, especially in something as fundamental as sexual health,” Chin-Yee said in a statement as she hopes her film sparks a wider conversation about a more equitable healthcare system.

Let’s Get to the Root Cause

The film is executive produced by Bristow, Greensfelder, Chin-Yee, Vibika Bianchi and Knix founder and president Joanna Griffiths, a backer of Docs for Change, a collaboration between Catalyst, the Toronto-based studio, and Knix Fund, the charity arm of the Knix brand. Sign up for THR news straight to your fildena 150 mg tablet inbox every day Just days after the U.S. Food and Drug Administration approved Addyi — the first prescription drug designed to boost sexual desire in women — Canadian company Valeant Pharmaceuticals announced they would be purchasing drug’s maker, Sprout Pharmaceuticals, for $1 billion. Valeant said that they expect the drug to be available in the United States sometime in the fourth quarter of 2015. The drug is being marketed as the “female viagra” however the two drugs couldn’t be more different. But when she saw the numbers and the science on that screen, “lightning struck.” Cindy spent the next year working with the “best sexual medicine doctors in the world” and listening to female patients share their experiences. “They came from all walks of life, but every person’s story at some point was exactly the same,” she recalls. This is the same struggle.” Despite being in happy relationships, these women had little to no sexual desire. When they were intimate with their partners, it often took the form of “mercy sex,” because they loved their partner and wanted them to feel pleasure, even though the women weren’t experiencing any themselves. The worst part: They didn’t know why they felt this way—and all of the so-called solutions (date nights, relaxing bubble baths, etc.) didn’t work. Those real-talk conversations were Cindy’s secret fuel as she sold Slate Pharmaceuticals, founded Sprout Pharmaceuticals, and began the grueling six-year FDA approval process for Addyi, the first medication designed to treat HSDD in premenopausal women.