Evaluation of safety for flibanserin

ABSTRACT

Introduction: Hypoactive sexual desire disorder (HSDD) is the most prevalent sexual dysfunction in women, previously managed with off-label therapies. Indicated for premenopausal women, flibanserin is the first FDA-approved medication to treat HSDD.

Areas covered: This review summarizes flibanserin’s pharmacokinetics, proposed mechanism of action, and safety data in clinical trials with a focus on sedation- and hypotension-related adverse events, and drug interactions with alcohol and antidepressants. Sources included peer-reviewed publications and internal data from the manufacturer.

Expert opinion: Flibanserin is a well-tolerated and effective treatment that decreases distress and restores sexual desire to a level that is normative for the individual patient with HSDD. Simplification of a risk mitigation program for flibanserin in the US is likely to increase the number of prescribing clinicians if accompanied with educational efforts to clarify flibanserin’s risk-benefit profile. As flibanserin is dosed daily and may be used for a decade or more in the typical premenopausal patient, long-term pharmacovigilance data will be essential. Over time, HSDD will be treated by more nonspecialist health care professionals and flibanserin will likely become established as a significant treatment option along with other medications approved for this indication in the context of a holistic biopsychosocial treatment paradigm.

KEYWORDS:

• Flibanserin
• serotonin
• 5-HT_1A receptor
• 5-HT_2A receptor
• hypoactive sexual desire disorder
• hypotension
• syncope
• alcohol interaction

Box 1. Drug summary

Declaration of interest

AH Clayton has received grants from Allergan, Endoceutics, Inc., Janssen and Sage Therapeutics; advisory board fees/consultant fees from Acadia, Alkermes, Allergan, AMAG Pharmaceuticals, Inc., Daré Bioscience, Fabre-Kramer, Ovoca Bio plc, Palatin Technologies, S1 Biopharma, Sage Therapeutics, Sprout Pharmaceuticals and Takeda/Lundbeck; royalties/copyright from Ballantine Books/Random House, Changes in Sexual Functioning Questionnaire and Guilford Publications; and has shares/restricted stock units with Euthymics and S1 Biopharma. L Brown is an employee of Sprout Pharmaceuticals, US. NN Kim has received research funding from Sprout Pharmaceuticals; and is a consultant for AMAG Pharmaceuticals, Sprout Pharmaceuticals, and Strategic Science and Technologies. 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 paper was funded by Sprout Pharmaceuticals.