(368) Real World Survey Study to Explore the Effects of Flibanserin in Men with Sexual Dysfunction

Abstract

Abstract Introduction Low sexual desire (LSD) is a syndrome of symptoms including diminished sexual interest or desire and absence of sexual thoughts or fantasies. Hypoactive sexual desire disorder (HSDD) is a subtype of persistent LSD associated with marked distress with no known cause. LSD/HSDD in men frequently occurs with other sexual dysfunctions such as erectile dysfunction and delayed orgasms. Flibanserin is a centrally-acting serotonergic medication approved in the United States to treat acquired, generalized HSDD in certain premenopausal women. Improvement in symptoms following the initiation of flibanserin treatment may take up to eight weeks. Objective Given the paucity of research available on the off-label use of flibanserin in men, this survey study was conducted to capture general information on the safety and outcomes of flibanserin in men with LSD/HSDD. Methods Dispensing data from sexual health clinics were used to identify males older than 18 years prescribed flibanserin between July 1 to December 31, 2022. Invitational emails containing a secure survey link were sent to eligible males. Survey questions captured changes in sexual function and sleep quality during active treatment. Patients not currently on treatment were excluded from the survey after the first question. In addition, 10-minute physician interviews were conducted to capture general safety information and outcomes. Study results are summarized using descriptive statistics. Results Thirty-four of 75 eligible males (45%) from 5 centers responded to the survey. The mean age was 55 years (range 30 to 81 years). Among respondents actively taking flibanserin (n=20), 12 selected low sexual desire, and 8 selected difficulties in reaching orgasm as their primary indication. Eleven of 16 respondents (69%) with treatment durations longer than 2 months indicated treatment-related benefits since starting flibanserin (TABLE). For the sleep quality question, 53% reported no change, 31% reported some improvement, and 16% reported worsening sleep. The most common reasons cited by physicians for treatment discontinuation were lack of effect and insomnia, followed by somnolence and fatigue. Conclusions Select male patients at sexual health clinics may experience benefits in LSD/HSDD and the ability to reach orgasm following 2 months of flibanserin treatment. Physician interviews suggest flibanserin is well tolerated in men with a safety profile similar to women. It is important to acknowledge survey study limitations when interpreting these findings. These results suggest that more research on the use of flibanserin in men with sexual dysfunctions is warranted. Disclosure Yes, this is sponsored by industry/sponsor: Sprout Pharmaceuticals, Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Sprout Pharmaceuticals, Inc.