Drugs in early clinical development for the treatment of female sexual dysfunction

Abstract

Introduction: There is growing recognition of female sexual dysfunction (FSD) as an important women’s health concern. Despite an increased awareness of the pathophysiologic components to FSD, currently, there are no drugs approved for the most common sexual complaint in women–decreased sexual desire. In response to an overwhelming demand for therapy for FSD, several drugs are undergoing development and testing.

Areas covered: The aim of this paper is to provide the latest data on pharmacological treatments for FSD currently in Phase I and II clinical trials. These include topical alprostadil, bremelanotide (BMT), intranasal testosterone (TBS-2), intravaginal dehydroepiandrosterone (DHEA), sublingual testosterone with sildenafil, apomorphine (APO), bupropprion and trazodone. It should be noted that the definitions of FSD have recently been revised in the diagnostic and statistical manual for mental disorders (DSM) 5, with merging of hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD) into female sexual interest/arousal disorder (FSIAD). However, it is noted that the majority of clinical trials discussed in this paper use the DSM IV-R diagnoses of HSDD and FSAD.

Expert opinion: Medications in early phase trials show promise for the treatment of FSD. These therapies focus on treating many possible causes of FSD. Concerns over gender bias within the FDA need to be resolved given the need for new treatment options for FSD.

Keywords:

• apomorphine
• bremelanotide
• female sexual dysfunction treatment
• intranasal testosterone
• intravaginal dehydroepiandrosterone
• testosterone with 5-hydroxytryptamine_1A receptor agonist
• testosterone with phosphodiesterase type 5 inhibitor
• topical alprostadil

Declaration of interest

AT Goldstein is on the advisory board for Emotional Brain LLC, and Strategic Science and Technologies, LLC. 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.

Notes

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