Expert opinion on existing and developing drugs to treat female sexual dysfunction

ABSTRACT

Introduction: Female sexual dysfunction (FSD) is a highly prevalent, yet commonly underdiagnosed and undertreated condition. This paper reviews the diagnostic terminology for FSD, and basic sexual physiology in women. The Food and Drug Administration (FDA) approved drugs for FSD are discussed, followed by investigational drugs for FSD currently in phase 2 or 3 clinical trials, reasons for failure of drug development, and potential future drug targets.

Areas covered: A literature review was conducted for available treatments for FSD: flibanserin, estrogen, ospemifene and prasterone. Potential treatments are assessed, as was the Pharmaprojects database which includes clinical trial information. Testosterone, bremelanotide, bupropion-trazodone, PDE-5 inhibitors, prostaglandins, tibolone and combination therapies, and the theoretical basis of potential drug targets are discussed.

Expert opinion: The lack of established endpoints for phase 3 studies of FSD has impeded approval of new treatments, and required additional studies for validation, resulting in proposed changes to the FDA draft guidance for FSD clinical trials in October 2016. Current DSM-5 diagnostic nosology also fails to capture the full range of symptomology. Several promising compounds have shown no movement for several years limiting women’s options. Overcoming socio-cultural bias against women’s sexual and reproductive health will be critical in the approval of new treatments for FSD.

KEYWORDS:

• Female sexual dysfunction
• hypoactive sexual desire disorder
• flibanserin
• ospemifene
• prasterone

Declaration of interest

A Clayton has receieved grants from Axsome, Endoceutics, Inc., Janssen, Palatin Technologies, Sage Therapeutics and Takeda. She has recieved advisory board/consulting fees from Alkermes, AMAG Pharmaceuticals, Inc., Ivix, Palatin Technologies, S1 Biopharma, Sage Therapuetics, Sprout Pharmaceuticals, Takeda and Valeant Pharmaceuticals. A Clayton recieves royalties/copyright fees from Ballantine Books/Random House; Changes in Sexual Functioning Questionnaire and Guildford Publications. She holds Shares/Restricted Stock Units in Euthymics and S1 Biopharma. 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

A reviewer on this manuscript has disclosed that they are a consultant and/or paid speaker for Menarini, Otsuka, Pfizer, Bayer, Shionogi, Lunbeck and Ibsa.

Additional information

Funding

This paper was not funded.