Pharmacotherapy for female sexual dysfunctions (FSDs): what is on the market and where is this field heading?

ABSTRACT

Introduction

Female sexual dysfunctions (FSDs) are common in women of any age and have a huge impact on quality of life and relationships. They have a multifaceted etiology limiting the development of pharmacotherapies with a high rate of effectiveness. Safety issues are also a concern.

Areas covered

The authors report the most recent advances in pharmacotherapy for premenopausal and postmenopausal women with a main focus on hypoactive sexual desire disorders (HSDD) and associated sexual symptoms. Good levels of evidence have emerged for psychoactive agents, such as flibanserin and bremelanotide, as well as hormonal compounds (transdermal testosterone). The authors also report briefly on intravaginal DHEA (prasterone), local estrogen therapy (LET), and ospemifene to manage effectively vulvovaginal atrophy/genitourinary syndrome of menopause (VVA/GSM). In addition, they discuss promising therapeutic options highlighting the main reasons that hamper the availability of new labeled products. Finally, they include the importance of the multimodal approach to address FSDs.

Expert opinion

Approved pharmacotherapies for FSD are limited. Validated multidimensional instruments and adequate objective measures of physical and mental responses to sexual external and internal incentives are mandatory to identify women suitable to chronic or on-demand treatments and to assess their pattern of response in research and practice.

KEYWORDS:

• Bremelanotide
• dehydroepiandrosterone (DHEA)
• flibanserin
• genitourinary syndrome of menopause (GSM)
• hypoactive sexual desire disorder (HSDD)
• local estrogen therapy (LET)
• ospemifene
• psychoactive drugs
• testosterone
• vulvovaginal atrophy (VVA)

Article highlights

• The biopsychosocial model is essential to diagnose and treat FSDs, as well as to guide the development of new pharmacotherapies and multimodal approaches.

• The DSM-V disorder named female sexual interest/arousal disorder (FSIAD) merged hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD) into a new entity not well captured by the validated psychometric tools available for diagnosis.

• Premenopausal and postmenopausal women should follow a standard process of care (POC) to establish an adequate therapeutic plan.

• Hypoactive sexual desire disorder (HSDD) and associated sexual symptoms may be treated with two approved psychoactive agents (flibanserin on a daily basis and bremelanotide on-demand) in premenopausal women and with daily transdermal testosterone (approved for use in males) at the physiological dose in postmenopausal women.

• Other psychoactive agents (bupropion, buspirone, and trazodone) are used off-label in the management of FSDs, especially when associated with antidepressant agents.

• Evidence-based treatments [local estrogen therapy (LET), intravaginal dehydroepiandrosterone (DHEA), oral Ospemifene] are available to manage vulvovaginal atrophy/genitourinary syndrome of menopause (VVA/GSM) to avoid the negative vicious circle that may lead to HSDD in postmenopausal women.

• Only few of the most recent candidate drugs to treat FSDs are in late development due to low levels of evidence.

• Two on-demand oral combined drugs [Lybrido: sildenafil (50 mg) plus testosterone (0.5 mg) and Lybridos: testosterone (0.5 mg) with buspirone (10 mg)] aim to treat FSIAD, due to lack of sensitivity to excitation and dysfunctional sexual inhibition, respectively. The novel combination of bupropion and trazodone at different dosages (Lorexys) offers another potential multifunctional solution.

Declaration of interest

RE Nappi has had a financial relationship (lecturer, member of advisory boards, and/or consultant) with Astellas, Bayer, Boehringer Ingelheim, Eli Lilly and Company, Endoceutics, Fidia, Gedeon Richter, HRA Pharma, Merck Sharp & Dohme, Novo Nordisk, Organon & Co, Palatin, Pfizer Inc, Procter & Gamble Co, Shionogi Limited, TEVA Women’s Health Inc, and Theramex. 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 of this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This manuscript was not funded.