FDA Grants Priority Review for Addyi® (flibanserin) Paving the Way for Expanded Access to Treat Low Sexual Desire in Postmenopausal Women

Addyi is the first and only FDA-approved, hormone-free pill clinically proven to treat low sexual desire in women

RALEIGH, N.C., July 24, 2025 /PRNewswire/ -- Sprout Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental application to expand the indication of Addyi® (flibanserin 100mg), the first and only FDA-approved pill for low sexual desire in women, to also include women who have gone through menopause.

This marks a potential pivotal advancement in women's sexual health, addressing a long-standing unmet need for millions of women experiencing hypoactive sexual desire disorder (HSDD). While nearly 40% of women will experience low sexual desire at some point in their lives, women beyond their reproductive years still do not have a single FDA approved medical treatment option.

"This isn't just a regulatory milestone — it's cultural recognition," said Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals. "Sexual desire is ageless. Access to care should be too. Priority Review brings us closer to expanding access and empowering more women with a science-backed, FDA approved solution for their sexual wellness."

The FDA's Priority Review designation is reserved for drugs that offer significant improvements in treatment for serious unmet medical needs. With enhanced focus and tighter timelines granted by the Agency, this designation underscores the urgency and importance of closing the gap in women's sexual healthcare.  

Following the FDA's recent public meeting on removing outdated estrogen labeling, Addyi's Priority Review reflects the same urgency and momentum signaling the Agency's commitment to ensuring that women at every life stage receive evidence-based care grounded accurately with the current science and focused on improving their quality of life.

Backed by the largest clinical trials in women's sexual health, Addyi originally received FDA approval for premenopausal women. After reviewing its robust safety and efficacy profile, Health Canada also approved Addyi with expanded use in women that have gone through menopause. Now the FDA has the data to potentially do the same.

"This is about expanding access, expanding awareness, and expanding agency for women who have been overlooked for far too long," Eckert added.

If approved, the updated Addyi label will mark a major shift toward inclusive, life-stage-spanning innovation in sexual health, recognizing that women deserve options no matter their age. 

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 remains committed to advancing science, expanding access, and advocating 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 25,000 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