Resources

Vyleesi for Hypoactive Sexual Desire Disorder (HSDD)

Posters and Presentations on Vyleesi for HSDD and FSD

The following poster presentations made at scientific and medical conferences report on results of the Phase 2B clinical trial with Vyleesi, the trade name for bremelanotide, for female sexual dysfunction.

Conversations With Women About Female Sexual Dysfunction (FSD) and Treatment With Bremelanotide

2016-November

Female sexual dysfunctions (FSD) include a range of distressing, multifactorial conditions, such as dysfunctions of sexual interest/desire, sexual arousal, a delay in or absence of orgasm, and sexual pain.1,2 The most common sexual concern expressed by women is diminished or lack of desire for sexual activity,3,4 which may be diagnosed as hypoactive sexual desire disorder (HSDD), if the lack of desire causes distress. Bremelanotide (BMT), a novel cyclic 7-amino acid melanocortin-receptor agonist with the potential to modulate neural pathways involved in sexual response,5,6 is being developed to treat FSD.

Safety and Efficacy of Bremelanotide for HSDD in Women: RECONNECT Study Open-Label Extension Phase Results

2018-April

Results from the Core Study Phase have been reported previously. This presentation includes long-term safety and efficacy results from the RECONNECT Open-Label Extension (OLE) Study Phase.

The Neurobiology and Efficacy of Bremelanotide in HSDD

2016-November

Describes how bremelanotide (BMT; PT-141), an analog of the naturally occurring peptide α-melanocyte-stimulating hormone (α-MSH), acts on the physiological and neurobiological components of female sexual function to improve sexual arousal and desire in women with HSDD.

Bremelanotide for Hypoactive Sexual Desire Disorder: Age and Weight Subgroup Efficacy Analyses From the RECONNECT Studies

2018-April

Analyses of the co-primary and key secondary endpoints were performed as exploratory analyses for the age and weight subgroups of the RECONNECT studies to assess the consistency of BMT’s effect.

Exit Survey of Women With Hypoactive Sexual Desire Disorder Treated With Bremelanotide in the RECONNECT Studies Demonstrated Meaningful Treatment Benefits

2018-April

The objective of this survey was to understand the impact of HSDD in premenopausal women and to provide a deeper understanding of the effect and impact/meaningfulness of BMT beyond clinical trial results.

Development of a Patient-Centric Exit Study to Contextualize and Assess Meaningfulness of a Potential Treatment for Hypoactive Sexual Desire Disorder (HSDD)

2017-October

• Female sexual dysfunctions (FSD) include a group of conditions characterized by physiological, psychological, and social components.
• The most common sexual concern expressed by women with FSD is diminished or lack of desire for sexual activity. When accompanied by distress, this may be diagnosed as hypoactive sexual desire
disorder (HSDD).
• Bremelanotide (BMT; PT-141) is an investigational drug being developed as a treatment for HSDD in premenopausal women.

Efficacy of the Investigational Drug Bremelanotide in the RECONNECT Studies

2017-September

To evaluate the safety and efficacy of BMT 1.75 mg self-administered, as-desired, for the treatment of HSDD.

Changes in Sexual Functioning in the Bremelanotide RECONNECT Study

April 2017

Two Phase 3 studies assessed the efficacy and safety of a 1.75-mg dose of BMT administered on an as-desired basis for the treatment of HSDD. Here we present the secondary efficacy results.

Bremelanotide is Safe and Well-Tolerated in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD): Safety Results from the RECONNECT Studies

2017-April

Here we present the results of the safety evaluation of BMT from the double-blind phase of the 2 RECONNECT studies.

Reliability and Validity of the Elements of Desire Questionnaire in the Bremelanotide RECONNECT Study

2017-February

The primary objective of this secondary analysis was to evaluate the measurement properties of both versions of the EDQ in premenopausal women with HSDD. This included examining the factor structure and item characteristics, developing a scoring algorithm, exploring the relationship between the 2 versions, examining the instrument’s construct validity (convergent and known groups) and ability to detect change, and exploring interpretation thresholds.

Efficacy of Bremelanotide Among Women Completing the Core Phase of the RECONNECT Studies

2017-April

To evaluate the safety and efficacy of BMT 1.75 mg self-administered, as desired, for the treatment of HSDD.

Bremelanotide: A Review of Its Neurobiology and Treatment Efficacy for HSDD

2016-September

Bremelanotide is a novel melanocortin-receptor agonist with a potential to modulate brain pathways involved in sexual response.

Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-ranging trial

2016-May

The aim was to evaluate efficacy/safety of bremelanotide, a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women. In premenopausal women with female sexual dysfunctions, self-administered, as desired, subcutaneous bremelanotide was safe, effective, and well tolerated.

A Placebo-Controlled, Randomized, Double-Blind, Three Period, Three-Way Crossover Study on the Hemodynamic and Pharmacokinetic Interactions of Bremelanotide and Ethanol

2016-October

In healthy adult women and men, single intranasal doses of bremelanotide with or without oral ethanol intake were safe and generally well tolerated.

Reliability and Validity of the Female Sexual Distress Scale–Desire/Arousal/Orgasm Instrument in a Phase 2B Dose-Ranging Study of Bremelanotide

2017-May

Reliability and Validity of the Female Sexual Distress Scale–Desire/Arousal/Orgasm Instrument in a Phase 2B Dose‐Ranging Study of Bremelanotide

Effect of Self‐Administered Bremelanotide on Sexual Interest and Desire in Premenopausal Women with Female Sexual Dysfunctions

2014-May

In these Sexual Interest and Desire Inventory-Female (SIDI-F) questionnaire findings, subcutaneous bremelanotide self-administered on an as-needed basis by premenopausal women with female sexual dysfunction (FSD) showed robust efficacy versus placebo, corroborating previous findings of clinically and statistically significant improvements of sexual function in women using on-demand bremelanotide for FSD. Treatment effect was most prominent in SIDI-F items related to desire and arousal. Because baseline was defined as each subject’s month of single-blind placebo self-dosing, efficacy was in addition to the substantial placebo effect commonly seen in FSD studies. Bremelanotide was generally safe and well tolerated.

Distress Reduction in Female Sexual Dysfunctions: A Dose‐Ranging Study of Subcutaneous Bremelanotide

2014-April

In premenopausal women with hypoactive sexual desire disorder (HSDD), bremelanotide self-administered subcutaneously on an at-home, as-needed basis yielded improvements across 5 clinically relevant female sexual dysfunction (FSD) measures, with robust dose-dependence attaining statistical significance on all measures at 1.75 mg and at 1.25/1.75 mg pooled. Because baseline was defined as each subject’s month of single-blind placebo self-dosing, the demonstrated efficacy was in addition to the placebo effect commonly seen in FSD studies. Bremelanotide was generally safe and well tolerated.

Bremelanotide for Hypoactive Sexual Desire Disorder: Analyses From a Phase 2B Dose‐Ranging Study

2014-April

In premenopausal women with hypoactive sexual desire disorder (HSDD), bremelanotide self-administered subcutaneously on an at-home, as-needed basis yielded improvements across 5 clinically relevant female sexual dysfunction (FSD) measures, with robust dose-dependence attaining statistical significance on all measures at 1.75 mg and at 1.25/1.75 mg pooled. Because baseline was defined as each subject’s month of single-blind placebo self-dosing, the demonstrated efficacy was in addition to the placebo effect commonly seen in FSD studies. Bremelanotide was generally safe and well tolerated.

Bremelanotide for Female Sexual Dysfunctions: Responder Analyses From a Phase 2B Dose-Ranging Study

2014-April

In premenopausal women with female sexual dysfunction (FSD), bremelanotide self-administered subcutaneously on an at-home, as-needed basis exhibited dose-dependent efficacy by evaluations with a 28-day recall period, including a decrease in distress and an improvement in overall sexual function, and also episodically, by an increase in the number of sexually satisfying events (SSEs). For each of these efficacy measures, statistical significance versus placebo was seen at 1.75 mg and at 1.25/1.75 mg pooled. For each of these measures, the women also showed dose-dependent increases in responder rates defined by expert-determined minimally clinically important differences (MCIDs), with statistically significant differences from placebo at 1.75 mg and at 1.25/1.75 mg pooled. Because baseline was defined as each subject’s month of single-blind placebo self-dosing, efficacy was in addition to the substantial placebo effect commonly seen in FSD studies. Bremelanotide was generally safe and well tolerated.

Efficacy of Subcutaneous Bremelanotide Self-Administered at Home by Premenopausal Women With Female Sexual Dysfunction: A Placebo-Controlled Dose-Ranging Study

2013-March

Efficacy of Subcutaneous Bremelanotide Self‐Administered at Home by Premenopausal Women with Female Sexual Dysfunction: A Placebo‐Controlled Dose‐Ranging Study.