Study Shows Positive Preliminary Results of Flibanserin in Breast Cancer Patients Suffering from Low Libido

70% of women diagnosed with breast cancer report having sexual dysfunction; there are currently a lack of effective treatment options for these women

RALEIGH, N.C., March 15, 2022 /PRNewswire/ -- New research reports positive findings for the use of Addyi (flibanserin) tablets in breast cancer patients on endocrine therapy who are suffering from treatment- or disease- induced low libido. There are currently a lack of effective treatment options for these women suffering from Hypoactive Sexual Desire Disorder (HSDD), or loss of libido, and it is estimated that more than 16.5 million people live with and beyond cancer treatment in the United States.  The findings were presented at the Annual Meeting for The International Society for the Study of Women’s Sexual Health (ISSWSH).

Dr. Shari Goldfarb, a breast medical oncologist from Memorial Sloan Kettering Cancer Center and the study's primary investigator said, "Sexual dysfunction is one of the most common and unaddressed side effects of treatment among female cancer survivors.  As investigators, we wanted to conduct a study to help treat decreased libido, which is an often distressing symptom for women on endocrine therapy. This study evaluated the impact of flibanserin on decreased libido in women with breast cancer on endocrine therapy. The early results are promising and show that this study is on track to meet its pre-defined feasibility endpoint with most study participants showing significant benefit from flibanserin."

This ongoing study will enroll 30 women with breast cancer on endocrine therapy who are suffering from HSDD.  Preliminary results from the first 20 women completing 24 weeks of flibanserin therapy show the study is on track to meet its primary feasibility end point, with >70% of women completing the 24-week treatment period and 15% discontinuing the study early due to an adverse event, all of which occurred during the first two weeks of treatment. Adverse events included dizziness, insomnia, sleepiness, and nausea. No serious adverse events occurred in the study. In addition, most women reported increased sexual desire, increased number of satisfying sexual events (SSEs) and decreased associated distress after 8 weeks of treatment.

Cindy Eckert, CEO of Sprout Pharmaceuticals said, "My heart goes out to breast cancer survivors who often struggle with their low libido. These interim results on the use of flibanserin in this population are encouraging. We are grateful to Dr. Goldfarb and Sloan Kettering for taking on this groundbreaking research and sharing it with the medical community."

To this point, there are no FDA-approved medications for women with HSDD secondary to cancer or its treatment, and a recently published Phase II study found that bupropion was not more effective than placebo in improving sexual desire in female cancer survivors. Yet, it is estimated that 70% of women diagnosed with breast cancer report having sexual dysfunction; this includes disorders of sexual desire and sexual response. In Feb 2018, the American Society of Clinical Oncology (ASCO) published guidelines that recommend "For women with cancer who are having problems with sexual response, including desire, arousal, or orgasm, doctors should offer psychosocial and/or psychosexual counseling. For premenopausal women with HSDD, doctors may suggest flibanserin." The guidelines also state that "the panel noted that flibanserin has not been tested in women with a history of cancer or women taking hormonal therapy, so the risk/benefit analysis of this medicine for women who've been diagnosed with cancer is unclear." Dr. Goldfarb's study findings provide new data to help close this gap in medical knowledge.

About the Investigator-Initiated Study
The investigator-initiated prospective, observational study is being conducted through Memorial Sloan Kettering Cancer Center. A planned total of 30 women will be enrolled in the study from both an academic center and an alliance community site. The primary endpoint of this study is to evaluate the feasibility of flibanserin 100 mg orally at bedtime for 24 weeks in women with breast cancer on endocrine therapy. Secondary endpoints include the efficacy of flibanserin as measured by the number of SSEs per month, change in desire, change in sexual function, quality of life, and distress from sexual function. Additional information is available at https://clinicaltrials.gov/ct2/show/record/NCT03707340.

Study Results from ISSWSH Presentation
Results from an analysis of the first 20 women enrolled in the study presented by Dr. Goldfarb at the ISSWSH Annual meeting found the study is on track to meet its pre-defined feasibility endpoint. Data was shared for the more than 70% of the study patients enrolled so far that have completed 24 weeks of flibanserin therapy. These preliminary findings also found improvements in libido, number of satisfying sexual events (SSEs), and decreased associated distress.

• Low libido was measured using a validated questionnaire called the Female Sexual Function Index (FSFI) total and FSFI- desire (FSFI-d) subdomain score. The baseline mean FSFI score was 13.3, with a desire score of 1.96. After 8 weeks on flibanserin mean FSFI total score increased to 19.4, and the mean FSFI-d score increased to 3.3.
• All study participants except one reported 0 SSEs per month at baseline, which increased to 2.2 per month after 8 weeks of treatment.
• Associated distress was measured using the validated Female Sexual Distress Scale-Revised (FSDS-R) total score and the score to Question 13 (FSDS-R13). Mean FSDS-R total scores decreased from 32 to 25, and FSDS-R13 scores decreased from 3.33 to 2.86 at 8 weeks of treatment.

ABOUT SPROUT PHARMACEUTICALS

Sprout Pharmaceuticals, Inc. is passionate about women's sexual health. Based in Raleigh, N.C., the company is focused solely on the delivery of a treatment option for women with HSDD. For more information call 1-844-PINK-PILL (1-844-746-5745).

ABOUT ADDYI

Addyi is an FDA-approved non-hormonal pill for acquired, generalized hypoactive (low) sexual desire disorder (HSDD) in certain premenopausal women.

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 enhance sexual performance.

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 take ADDYI and:

• drink alcohol close in time to when you take your ADDYI dose.
  • Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking ADDYI at bedtime. 
    • Examples of 1 standard alcoholic drink include: one 12-ounce regular beer, 5 ounces of wine, 1.5 ounces of distilled spirits or shot
  • If you drink 3 or more standard alcoholic drinks in the evening, skip your ADDYI dose at bedtime.
  • After you have taken your ADDYI at bedtime, do not drink alcohol until the following day.
• take certain prescription medicines, over-the-counter medicines, or herbal supplements. Do not take or start taking any prescription medicines, over-the-counter medicines, or herbal supplements while taking ADDYI until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking ADDYI.
• have liver problems. 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 (lose consciousness), 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
• Nausea
• Tiredness
• Difficulty falling asleep or staying asleep
• Dry mouth

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.

CONTACT INFORMATION 
[email protected]
844-746-5745 x 2000

US--2200026.02

SOURCE Sprout Pharmaceuticals

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