An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder

ABSTRACT

Introduction

Female sexual response implies a deep intertwining between psychosocial and neurobiological mediators. Regulation of central melanocortin signaling may enhance sexual desire. In premenopausal women with hypoactive sexual desire disorder (HSDD), melanocortin receptor agonist bremelanotide (Vyleesi) has been hypothesized to trigger excitatory brain pathways.

Areas covered

Hereby we summarize bremelanotide’s proposed mechanism of action, pharmacokinetics, efficacy and safety data derived from clinical trials. A literature search of peer-reviewed publications on the current evidence on the pharmacotherapy with bremelanotide was performed using the PubMed database.

Expert opinion

Bremelanotide appears to be moderately safe and well-tolerated; the most common adverse reaction is nausea (40%). Although data from clinical trials demonstrated a significant change in validated questionnaires, the overall clinical benefit appears to be modest. However, these results should be interpreted in the light of the dramatic challenges in conducting well-designed clinical trials for female sexual dysfunction, due to the significant placebo effect of pharmacotherapy, and the frequent use of outcome measures that are likely to be highly susceptible to expectation biases, such as long periods of recall of sexual and emotional response.

KEYWORDS:

• Female sexual dysfunction
• bremelanotide
• hypoactive sexual desire disorder
• female sexual distress

Declaration of interest

L Vignozzi has received funding for scientific research, advisory board attendance and speaker honoraria from Therascience, Theramex, Bayer Schering Pharma, Intercept, Lipocine, Ibsa. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This research was supported by a PRIN grant (‘Progetti di Rilevante Interesse Nazionale’: 2017S9KTNE).