(369) Physician Insights into the Safety of Flibanserin for the Treatment of Sexual Dysfunction in Men

Abstract Introduction Hypoactive sexual desire disorder (HSDD) is a subtype of persistent low sexual desire (LSD) associated with marked distress with no known cause. LSD/HSDD in men frequently occurs with other sexual dysfunctions. Flibanserin is a centrally-acting multifunctional serotonin agonist and antagonist approved in the United States (US) to treat acquired, generalized HSDD in certain premenopausal women. Based on its proposed mechanism of action, flibanserin is prescribed off-label to treat sexual dysfunction in men. Objective Given the lack of safety data in men, this study was conducted to capture insights from physicians on the safety of flibanserin in their male patients. Methods Dispensing data from two specialty pharmacies were used to identify physicians with experience treating male patients with flibanserin (physicians). Physicians were invited via email to participate in a brief 10-minute interview. All interviews were conducted using a standardized questionnaire containing 6 questions. The questionnaire captured general safety information and types of sexual dysfunction treated with flibanserin. Physicians were instructed not to share any patient-specific information. Interviews were conducted with each physician individually via video conference. Responses to questions were documented verbatim and summarized descriptively. Results Six physicians from different sexual health clinics in the US were invited to participate in the study, 5 of which accepted the invitation and completed the interview. All physicians prescribed flibanserin to treat LSD/HSDD. Other sexual dysfunctions treated with flibanserin included delayed orgasm (n=4), post-orgasmic illness syndrome (n=2), antidepressant (SSRI)-induced sexual dysfunction (n=2), and post-finasteride-associated sexual dysfunction (n=1). Physicians reported their male patients experienced similar but less frequent or severe side effects than reported in premenopausal women during the HSDD clinical trials, including somnolence/sleepiness (n=3), insomnia (n=2), fatigue (n=1) and dry mouth (n=1). The most frequent physician-cited side effects leading to flibanserin discontinuation were insomnia (n=2), somnolence (n=1), fatigue (n=1), and dizziness (n=1). Lack of effect was another common reason (n=3) for treatment discontinuation. No physicians reported any unanticipated flibanserin-related side effects in their male patients. Although interviews included no efficacy-related questions, physicians provided insight into flibanserin response rates they observed in their male patients when responding to safety questions, including positive response rates in LSD/HSDD and other sexual dysfunctions such as delayed orgasm. Conclusions Feedback from the participating sexual medicine physicians suggests that flibanserin may have a similar safety profile in men as observed in premenopausal women. It is reassuring that physicians reported no unanticipated or severe safety concerns in their male patients. In addition to LSD/HSDD, physicians reported positive response rates with flibanserin in their male patients treated for other sexual dysfunctions. The generalizability of these findings to other practice settings is limited. However, these safety findings and reports of positive response rates in male patients with LSD/HSDD and other sexual dysfunctions 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.