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

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.

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.

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.