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).

开始日期2020-05-08

申办/合作机构

Baylor College of Medicine

[+1]

NCT01188603 / Completed临床1期

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.

开始日期2010-07-01

申办/合作机构

Sprout Pharmaceuticals, Inc.

NCT01103362 / Terminated临床3期

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).

开始日期2010-04-01

申办/合作机构

Sprout Pharmaceuticals, Inc.

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项与 Sprout Pharmaceuticals, Inc. 相关的文献（医药）

2022-02-01·Sexual medicine3区 · 医学

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

3区 · 医学

ArticleOA

作者: 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.

2019-10-01·Sexual medicine reviews2区 · 医学

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

2区 · 医学

Review

作者: 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.

2019-06-01·Journal of women's health (2002)3区 · 医学

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

3区 · 医学

Article

作者: 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.

项与 Sprout Pharmaceuticals, Inc. 相关的新闻（医药）

2023-12-20

·FiercePharma

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.