The purpose of this study is to determine if the study drug will increase sexual desire in men with HSDD. Half of the participants will take ADDYI while the other half will receive a placebo (a look-alike pill with no medicine).

Start Date08 May 2020

Sponsor / Collaborator

Baylor College of Medicine

[+1]

NCT01188603 / CompletedPhase 1

Evaluation of Single Dose and Steady State Pharmacokinetics of Flibanserin Postmenopausal Women With Hypoactive Sexual Desire Disorder

This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder.

Start Date01 Jul 2010

Sponsor / Collaborator

Sprout Pharmaceuticals, Inc.

NCT01103362 / TerminatedPhase 3

Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD

To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

Start Date01 Apr 2010

Sponsor / Collaborator

Sprout Pharmaceuticals, Inc.

100 Clinical Results associated with Sprout Pharmaceuticals, Inc.

0 Patents (Medical) associated with Sprout Pharmaceuticals, Inc.

Literatures (Medical) associated with Sprout Pharmaceuticals, Inc.

01 Feb 2022·Sexual medicineQ3 · MEDICINE

Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin

Q3 · MEDICINE

ArticleOA

Author: Clayton, Anita H. ; Simon, James A. ; Patel, Sejal ; Kim, Noel N.

Abstract:

Background:

The efficacy of flibanserin in treating hypoactive sexual desire disorder (HSDD) is based upon statistically significant improvements in sexual desire, satisfying sexual events, and distress. However, clinically meaningful benefit has not been well characterized.

Aim:

Evaluate clinically meaningful benefit of flibanserin.

Methods:

Data were pooled from 3 pivotal trials evaluating flibanserin 100 mg qhs in premenopausal women (flibanserin, n = 1192; placebo, n = 1215). Flibanserin trial data in postmenopausal women (flibanserin, n = 450; placebo, n = 476) were analyzed separately. Clinically meaningful benefit was evaluated by the Patient Global Impression of Improvement (PGI-I). Responders were determined through anchor-based analyses that used the PGI-I for key efficacy endpoints: satisfying sexual events (SSE), desire domain of the Female Sexual Function Index (FSFI-d), and distress associated with decreased sexual desire (FSDS-R13). Odds ratios were calculated to assess effect size and Kaplan-Meier analyses were performed to estimate onset time for treatment benefit.

Outcomes:

PGI-I, anchor-based analyses for key efficacy endpoints (SSE, FSFI-d, FSDS-R13), odds ratios, onset time for treatment benefit.

Results:

Based on the PGI-I, more patients reported clinically meaningful benefit with flibanserin treatment versus placebo (49.8% vs 33.6%, premenopausal cohort; 40.5% vs 28.7%, postmenopausal cohort). In anchor-based analyses, responder rates were significantly higher for premenopausal women on flibanserin (46.1%–55.2%) than placebo (34.1%–44.2%) for all 3 key efficacy endpoints (P < .0001). Responder rates for postmenopausal women on flibanserin were higher compared to placebo for SSE (29.8% vs 22.9%; P = .015) and FSFI-d (38.9% vs 26.3%; P = .0001). Odds ratios for key endpoints indicated that premenopausal women were 2.0–2.4 times as likely to be responders with flibanserin treatment compared to placebo. Postmenopausal women were 1.6 times as likely to be responders with flibanserin for FSFI-d. Kaplan-Meier analyses indicated significant separation between flibanserin and placebo for the key endpoints in both premenopausal and postmenopausal cohorts (log-rank tests P < .01) with earlier median response times among patients receiving flibanserin.

Clinical Implications:

Patient-reported benefit assessments such as the PGI-I capture the patient's perspective and may be a useful approach in assessing overall clinical meaningfulness for sexual dysfunction therapies.

Strengths and Limitations:

Strengths include a well-powered study with large enrollment, use of validated instruments, and self-assessment of treatment benefit. Limitations include pooling of trial data in premenopausal women with slightly different study designs and use of an endpoint (SSE) indirectly related to HSDD.

Conclusion:

Assessment of clinically meaningful benefit and additional responder analyses provide further support for flibanserin's efficacy beyond numerical improvements in endpoint measures.

01 Oct 2019·Sexual medicine reviewsQ2 · MEDICINE

Weight Loss in Women Taking Flibanserin for Hypoactive Sexual Desire Disorder (HSDD): Insights Into Potential Mechanisms

Q2 · MEDICINE

Review

Author: Simon, James A ; Millheiser, Leah ; Goldstein, Irwin ; Kim, Noel N ; Hakim, Brittany ; Kingsberg, Sheryl A

INTRODUCTION:

Flibanserin, a multifunctional serotonin receptor agonist and antagonist, is currently approved in the United States and Canada for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. A post hoc analysis of HSDD clinical trial data found that flibanserin treatment was associated with statistically significant weight loss relative to placebo, even though study patients were not selected for being overweight/obese and were provided no expectation for weight reduction or interventions intended to promote weight loss.

AIM:

To understand possible mechanisms by which flibanserin may produce weight loss.

METHODS:

A literature review was performed using Medline database for relevant publications on the mechanisms of action by which flibanserin may provide weight loss and the links between sexual function and weight management.

MAIN OUTCOME MEASURES:

Examination of (i) biopsychosocial factors regulating sexual desire, food intake, and weight regulation; (ii) clinical pharmacology of flibanserin; (iii) neurobiology of brain reward circuitry; and (iv) identification of possible mechanisms common to flibanserin and weight loss.

RESULTS:

Based on flibanserin clinical trial data, there was no consistent correlation between weight loss and improvement in sexual function, as assessed by HSDD outcome measures. Nausea, a common adverse event associated with flibanserin use, also did not appear to be a contributing factor to weight loss. Hypothetical links between flibanserin treatment and weight loss include modulation of peripheral 5-HT_2A receptors and factors such as improved mood and improved sleep.

CONCLUSION:

Mechanisms of flibanserin-induced weight loss have not been well characterized but may involve indirect beneficial effects on peripheral 5-HT_2A receptors and central regulation of mood and sleep. Future research may better elucidate the links between sexual function and weight management and the mechanism(s) by which flibanserin use may result in weight loss. Simon JA, Kingsberg SA, Goldstein I, et al. Weight Loss in Women Taking Flibanserin for Hypoactive Sexual Desire Disorder (HSDD): Insights into Potential Mechanisms. Sex Med Rev 2019;7:575-586.

01 Jun 2019·Journal of women's health (2002)Q3 · MEDICINE

Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials

Q3 · MEDICINE

Article

Author: Millheiser, Leah ; Thorp, John ; Simon, James A.

Background: Flibanserin, a 5-hydroxytryptamine 5-HT_1A agonist and 5-HT_2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis assessed pooled efficacy and safety data for flibanserin in premenopausal women with HSDD. Materials and Methods: Data for flibanserin 100 mg once daily at bedtime (qhs) and placebo were pooled from three pivotal 24-week, randomized, placebo-controlled, multicenter studies (VIOLET, DAISY, and BEGONIA) of premenopausal women with HSDD. Pooled efficacy endpoints included the change from baseline to study end (i.e., 24 weeks) in the number of satisfying sexual events (SSEs) over 28 days, the Female Sexual Function Index desire domain (FSFI-d) score, and the Female Sexual Distress Scale-Revised Item 13 (FSDS-R-13) score. Results: The analysis included 2465 women (flibanserin, n = 1227; placebo, n = 1238) with a mean age of 36 years and a mean HSDD duration of 56.5 months. The mean ± standard error (SE) change from baseline to study end in SSEs over 28 days for flibanserin versus placebo was 2.1 ± 0.14 versus 1.2 ± 0.11, respectively (p < 0.0001). The least-squares mean ± SE changes from baseline to study end in FSFI desire domain score and FSDS-R-13 score were also significantly greater for flibanserin versus placebo (FSFI desire domain: 0.9 ± 0.04 vs. 0.6 ± 0.04, p < 0.0001; FSDS-R-13: -0.9 ± 0.04 vs. -0.6 ± 0.04, p < 0.0001). Patients in the flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics. Adverse events occurring in ≥10% of patients included dizziness and somnolence. Conclusions: This pooled analysis of three pivotal trials demonstrated that flibanserin 100 mg qhs was well tolerated, improved sexual desire, and reduced sexual distress associated with HSDD in premenopausal women, and these improvements were generally consistent across various subgroups based on demographic and baseline characteristics.

News (Medical) associated with Sprout Pharmaceuticals, Inc.

20 Dec 2023

·www.fiercepharma.com

Palatin sells female libido drug Vyleesi to Cosette for $12M, plus more in potential milestones

Unable to generate strong momentum for Vyleesi, Palatin has sold the female libido drug to Cosette in a deal between two New Jersey companies. Palatin Technologies has sold its struggling female libido drug Vyleesi for $12 million to another New Jersey drugmaker Cosette Pharmaceuticals, in a deal that indicates the medicine is unlikely to ever make a significant impact in the market. Cosette also is on the hook for $159 million in contingent, sales-based milestones for the drug which was approved by the FDA in 2019. As one of two drugs hailed to potentially become the “female Viagra,” Vyleesi has not lived up to expectations. In September, when Palatin revealed its quarterly earnings, it reported fiscal-year sales of $12.5 million, compared to $5.8 million in the previous fiscal year. While Palatin CEO Carl Spana, Ph.D., said in a release that he was “excited” that Vyleesi’s net product revenue of $4.9 million for the year “continues to exceed Vyleesi quarterly operating expenses,” the results are far short of what the company and some experts had expected. Upon its approval, Barclays’ analyst Balaji Prasad pegged Byleesi’s potential sales in 2025 at $108 million. “The divestiture of Vyleesi is consistent with our strategic decision to concentrate on our robust development and clinical pipeline,” Spana said in a release. “Our focus now is solely on developing novel therapeutics that modulate the melanocortin receptor system.” Those candidates include a dry eye disease hopeful, which recently completed enrollment in a phase 3 study, and an ulcerative colitis drug which is in phase 2. Cosette CEO Apurva Saraf called Vyleesi an “important addition to our rapidly expanding women’s health platform.” Cosette will further compensate Palatin if it can push sales of Vyleesi to more than $15 million and up to $200 million. Palatin also is eligible for milestone payments of up to $10.5 million associated with previous licensing of Vyleesi to companies in China (Fosun) and South Korea (Kwangdong). Vyleesi is administered as a subcutaneous self-injection in a prefilled disposable autoinjector pen for use in anticipation of a sexual encounter. It was the first as-needed treatment approved by the FDA for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). In 2017, Palatin made a licensing agreement with AMAG Pharmaceuticals, which took over North America rights to the treatment. Three years later, the companies mutually agreed to terminate the agreement with AMAG paying Palatin $12 million upfront, plus a $4.3 million payment to Palatin on March 31, 2021. Sprout Pharmaceuticals was first with an answer for HSDD, winning approval for Addyi in 2015. Bausch Health, then Valeant, paid $1 billion to acquire the treatment and then sold it back to Sprout in 2017 in a 6% royalty agreement. Editor's Note: An earlier version of this story incorrectly stated that Palatin paid $12 million to regain the North American rights to Vyleesi in 2020.

Drug ApprovalLicense out/inAcquisitionPhase 3

02 Jun 2023

·www.biospace.com

Sprout Pharmaceuticals Announces Release of Abstract Reporting Positive Interim Results for Flibanserin in Breast Cancer Patients Suffering from Low Libido for Poster Discussion at 2023 ASCO Annual Meeting

70% of women diagnosed with breast cancer report having sexual dysfunction, this includes disorders of sexual desire and sexual response. RALEIGH, N.C., June 2, 2023 /PRNewswire/ -- Sprout Pharmaceuticals, Inc. a pharmaceutical company specializing in women's sexual health today announced publication of abstract 12015 by the American Society of Clinical Oncology (ASCO). The abstract reporting positive interim results for the use of Addyi (flibanserin) tablets in breast cancer patients with low libido has been accepted for presentation in a Poster Discussion Session at the ASCO 2023 Annual Meeting being held virtually and in Chicago, IL from June 2-6, 2023. The abstract is now available online on the ASCO conference website: Details of the poster presentation are as follows: Abstract Number: 12015 Poster Board Number: 383 Poster Title: Effect of flibanserin on libido in women with breast cancer on adjuvant endocrine therapy. Presenting Author: Shari Goldfarb, MD Session: Symptoms and Survivorship Date and Time: 6/5/2023, 4:30 PM-6:00 PM (CT) It is estimated that 70% of women diagnosed with breast cancer report having sexual dysfunction; this includes disorders of sexual desire and sexual response, yet there are no FDA-approved medications for women with HSDD secondary to cancer or its treatment. Dr. Shari Goldfarb, a breast medical oncologist from Memorial Sloan Kettering Cancer Center and the study's primary investigator said, "Decreased libido is an extremely prevalent, undertreated and distressing symptom in women with breast cancer on endocrine therapy. As investigators, we wanted to conduct a study to help treat decreased libido. This study evaluated the impact of flibanserin on decreased libido in women with breast cancer on endocrine therapy and shows that Flibanserin can be used safely and effectively in women with breast cancer. Flibanserin showed statistically significant improvement in not only libido, but also in the sexual domains of arousal, lubrication and ability to orgasm. Flibanserin should be offered to women with breast cancer with bothersome and medication-induced decreased libido. Having a medication to treat this often unaddressed issue will improve the quality of life and sexual function of millions of women with breast cancer." Cindy Eckert, CEO of Sprout Pharmaceuticals said, "Our mission at Sprout is to improve the lives of women by addressing their sexual health challenges. Seeing these interim results for Addyi in the breast cancer population is an important step in that mission." About the Investigator-Initiated Study The investigator-initiated prospective, observational study is being conducted through Memorial Sloan Kettering Cancer Center. A planned total of 43 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 . 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: 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 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 info@sproutpharma.com 844-746-5745 x 2000 US—2300041.01 View original content to download multimedia: SOURCE Sprout Pharmaceuticals

Clinical ResultASCO

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Drug(Targets)	Indications	Global Highest Phase

Flibanserin ( 5-HT1A receptor x 5-HT2A receptor x D4 receptor )	Sexual Dysfunctions, Psychological More	Approved

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