Addyi® Marks a Decade of Leadership in Women's Sexual Health

Ten years since the landmark approval of the first and only FDA-authorized pill clinically proven to treat low libido in women, Sprout Pharmaceuticals CEO Cindy Eckert reflects on advancements and signals the next breakthrough in closing the healthcare gender gap

RALEIGH, N.C., Sept. 4, 2025 /PRNewswire/ -- Sprout Pharmaceuticals proudly marks a major milestone for Addyi^® (flibanserin 100mg): the 10th anniversary of approval by the U.S. Food and Drug Administration (FDA) as the first and only FDA-approved pill for addressing low sexual desire in women. Since its approval, Addyi has blazed a trail in women's health, a field that had long been overlooked and underserved, dismantling barriers and shattering taboos around women's sexual wellbeing.

"Ten years ago, we shattered a glass ceiling in medicine with the FDA approval of Addyi — and it ignited a global conversation about women's sexual health, including the long-ignored realities of perimenopause and menopause. A decade later, our mission is as vital as ever: drive scientific innovation, expand access, and ensure women have real, evidence-based choices for their care," said Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals. "We're proud of what we've achieved, and with the prospect of expanded FDA approval on the horizon, we will continue to redefine what's possible in women's health and transform care for millions more women."

A Decade of Leadership
Bringing Addyi to market required persistence and bold advocacy. Sprout Pharmaceuticals, under Eckert's leadership, led a grassroots advocacy effort backed up by the largest clinical trials ever undertaken in women's sexual health. The company submitted data from over 13,000 patients—three times more than any male sexual health drug—to support its FDA application. This unprecedented effort led to the historic approval of Addyi in 2015, marking a major milestone in addressing Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

Hypoactive Sexual Desire Disorder (HSDD) is the most common form of female sexual dysfunction, and a recognized medical condition marked by a persistent lack of sexual desire that causes personal distress. Despite its prevalence, with at least 40% of women reportedly experiencing low sexual desire at some point in their lives, treatment options have been severely limited. Sometimes referred to as the "female Viagra" or "the little pink pill," Addyi works differently. Unlike treatments that target blood flow, Addyi is a non-hormonal medication that acts on key neurotransmitters in the brain to help restore sexual desire in premenopausal women.

Over the past decade, over 30,000 U.S. healthcare professionals have prescribed Addyi to their patients, empowering women to reclaim their sexual well-being and normalize conversations around desire and intimacy.

"I testified at the FDA 10 years ago when Addyi was approved — a watershed moment that validated women's sexual health with the first FDA approved option to treat women with low libido. In my practice, it opened conversations that had long been silenced and gave patients hope. A decade later, Addyi continues to break stigma and normalize sexual health as part of routine care," said Dr. Alyse Kelly-Jones, Ob/Gyn at Tryon Women's Center.

"It's hard to imagine a time before Addyi. This medication gave women a scientifically proven option for addressing one of the most common — yet previously overlooked — issues in their lives. It hasn't just changed the way I practice medicine; it has changed the lives of countless patients of mine," said Dr Jila Senemar, Ob/Gyn and Founder of JilaMD.

Today, Addyi is available for as low as $20/month with insurance and $199/month cash at Addyi.com. The medication does NOT carry a REMS (Risk Evaluation and Mitigation Strategy) requirement or alcohol contraindication per the updated Prescribing Information in 2019, further easing access for women seeking safe and effective treatment.

Looking Ahead
This year, the FDA granted Priority Review to Sprout Pharmaceuticals' supplemental application to expand Addyi's indication to also include women who have gone through menopause. If approved, this would dramatically widen access to treatment for millions more women wanting to address their sexual health at every stage of their lives.

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About Sprout Pharmaceuticals
Sprout Pharmaceuticals is leading a revolution in women's health, pioneering innovative treatments that address long-overlooked needs. With the launch of Addyi, the first and only FDA-approved pill to treat low sexual desire (HSDD), Sprout helped shift the conversation around women's sexual wellness. The company is focused on advancing science, expanding access, and setting a new standard for the care women deserve."

About Addyi ^® (flibanserin)
Addyi is the first and only FDA-approved pill to treat low libido (HSDD) in certain premenopausal women. Addyi is a non-hormonal medication, prescribed by over 30,000   U.S. healthcare professionals and growing. Addyi works on key neurotransmitters that affect sexual response. Before taking Addyi, you should consult with your doctor about all your medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Learn more at addyi.com

About Hypoactive Sexual Desire Disorder (HSDD)
Hypoactive Sexual Desire Disorder (HSDD), also known as frustrating low libido, is a persistent lack of sexual interest or desire. It is the most common form of sexual dysfunction in women, impacting an estimated 40% of women according to the Mayo Clinic.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ADDYI?
Your risk of severe low blood pressure and fainting (loss of consciousness) is increased:

• if you drink alcohol close to the time you take your ADDYI dose,
• if you take ADDYI with certain medicines, or
• if you have liver problems and you take ADDYI.

To lower your risk of low blood pressure and fainting (loss of consciousness):

• Do not drink alcohol close to the time you take your ADDYI dose
  • Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking ADDYI at bedtime.
  • Skip your ADDYI dose if you drink 3 or more standard alcoholic drinks that evening.
• After taking ADDYI at bedtime do not drink alcohol until the following day.

Examples of 1 standard alcoholic drink include:

• one 12-ounce regular beer
• 5 ounces of wine
• 1.5 ounces of distilled spirits or shot

Tell your doctor about other medicines you take. Do not take or start taking any prescription or over-the-counter medicines, or herbal supplements without first talking to your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking ADDYI.
Do not take ADDYI if you have liver problems.
If you take ADDYI and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you feel like you could faint (lose consciousness). If you faint, tell your doctor as soon as you can.
Who should not take ADDYI?
Do not take ADDYI if you:

• take certain medicines. Taking ADDYI with certain other medicines can increase the amount of ADDYI in your blood and cause severe low blood pressure, fainting (loss of consciousness), and sleepiness.
• Do not take ADDYI if you are taking any of the following medicines:
• Certain medicines used to treat HIV-1 infection
  • Certain medicines that you take by mouth used to treat fungal infections
  • Certain antibiotics
  • Certain medicines used to treat Hepatitis C infection
  • Certain medicines used to treat high blood pressure, chest pain (angina), or other heart problems
  • Nefazodone: a medicine used to treat depression
• Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above. These are examples of the medicines that you should not take if you are taking ADDYI. Tell your doctor about all the medicines you take before you start taking ADDYI
• have liver problems
• are allergic to flibanserin or any of the ingredients in ADDYI. See Medication Guide for the full list of ingredients.

What should I tell my doctor before taking ADDYI?
Before you take ADDYI, tell your doctor about all of your medical conditions, including if you:

• drink alcohol, use drugs, or have a history of alcohol or drug abuse
• have ever had depression or other mental health problems
• have low blood pressure or a medical condition that can cause low blood pressure
• are pregnant or plan to become pregnant. It is not known if ADDYI will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ADDYI passes into your breast milk.
  You and your doctor should decide if you will take ADDYI or breastfeed. You should not do both.

Tell your doctor if you have had an allergic reaction such as hives, itching, or trouble breathing during or after receiving a dose of ADDYI.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADDYI can affect the way other medicines work, and other medicines can affect the way ADDYI works, and can cause serious side effects.
What should I avoid while taking ADDYI?

• Do not drink alcohol close to the time you take your ADDYI dose because this increases your risk of severe low blood pressure and fainting (loss of consciousness).
• Do not drive, operate machinery, or do things that require clear thinking until at least 6 hours after you take ADDYI and until you know how ADDYI affects you.
• Do not drink grapefruit juice if you take ADDYI. Drinking grapefruit juice during your treatment with ADDYI increases your risk of severe low blood pressure and fainting (loss of consciousness).
• You should not take the herbal supplements St. John's Wort, ginkgo, or resveratrol or certain over-the-counter medicines such as cimetidine until you talk to your doctor. Taking ADDYI with these herbal supplements and over-the-counter medicines may increase your risk of low blood pressure, fainting (loss of consciousness), and sleepiness.

What are the possible side effects of ADDYI?
ADDYI can cause serious side effects, including:

• Sleepiness is a common side effect of ADDYI and can be serious. Taking ADDYI can increase your risk of sleepiness if taken during waking hours, if you drink alcohol, or take certain medicines or herbal supplements.
• Low blood pressure and fainting (loss of consciousness) can happen when you take ADDYI even if you do not drink alcohol or take other medicines or herbal supplements. Your risk of low blood pressure and fainting (loss of consciousness) is increased if ADDYI is taken during waking hours, if you drink alcohol within 2 hours of taking ADDYI, or if you take certain medicines or herbal supplements.

The most common side effects of ADDYI include:

• Dizziness
• Difficulty falling asleep or staying asleep
• Nausea
• Dry mouth
• Tiredness

These are not all of the possible side effects of ADDYI. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
See full Prescribing Information, including Boxed Warning regarding severe low blood pressure and fainting in certain settings, and Medication Guide at addyi.com/pi.
This information does not take the place of talking with your doctor.

INDICATION
What is ADDYI (add-ee) (flibanserin) Tablets?
ADDYI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to:

• a medical or mental health problem
• problems in the relationship
• medicine or other drug use.

ADDYI is not for use for the treatment of HSDD in women who have gone through menopause, in men or in children.
ADDYI is not for use to improve sexual performance.

SOURCE Sprout Pharmaceuticals