Flibanserin Efficacy and Safety in Premenopausal Women With Generalized Acquired Hypoactive Sexual Desire Disorder.

INTRODUCTION: Flibanserin is a postsynaptic 5-HT-1A agonist and 5-HT-2A antagonist for the treatment of generalized acquired hypoactive sexual desire disorder in premenopausal women.

AIM: To review and evaluate the efficacy and safety of flibanserin.

METHODS: We review and critique the appropriateness of the co-primary and secondary end points used in the flibanserin pivotal trial research program. We review the efficacy and safety parameters of this drug based on the published literature and related sources.

MAIN OUTCOME MEASURES: Pivotal trial primary and secondary end points and safety profile data from the flibanserin development program.

RESULTS: Our review identified instances of poor fit of two primary trial pivotal trial end points with the hypoactive sexual desire disorder construct: satisfying sexual events and electronic daily diary assessments of the most intense level of sexual desire experienced each day. Efficacy findings of the flibanserin pivotal trials program were positive for satisfying sexual events, not positive for electronic daily diary assessments of the most intense level of sexual desire experienced, and positive for secondary end points of the Female Sexual Function Index desire domain and overall measurements and the Female Sexual Distress Scale-Revised desire-specific and overall measurements. Safety data from the clinical trial program showed a reasonable safety profile.

CONCLUSION: Flibanserin has demonstrated efficacy on appropriate measurements of the hallmarks of hypoactive sexual desire disorder-experience of absent or decreased sexual desire that is persistent over time and distressing-and the safety profile of flibanserin is acceptable. Fisher WA, Pyke RE. Flibanserin Efficacy and Safety in Premenopausal Women With Generalized Acquired Hypoactive Sexual Desire Disorder. Sex Med Rev 2017:5;445-460.