Resources

Rekynda (bremelanotide) for Hypoactive Sexual Desire Disorder (HSDD)

Posters and Presentations on Rekynda for HSDD and FSD

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

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

September 2016

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

Women's Health, 12:325-337 (2016); Published online 16 May 2016

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

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

May 2014

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

May 2014

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

April 2014

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

April 2014

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

April 2014

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

March 2013

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