(036) Characterizing flibanserin’s safety profile among postmenopausal women with HSDD: An Exploratory Analysis

Abstract Introduction Flibanserin is approved in the United States (US) for premenopausal women and Canada pre naturally postmenopausal women, ≤60 years of age, to treat acquired, generalized hypoactive sexual desire disorder (HSDD). Clinical trials suggest that flibanserin's safety profile similar among pre-and women. During a Phase 3 study, most frequently reported adverse events (AEs) were dizziness (10%), somnolence (9%), nausea (8%), headache (6%). This study explores postmarketing AEs received from their clinicians during flibanserin treatment. Objective The primary objective this further characterize with HSDD treated clinical setting. Methods retrospective exploratory analysis captured global database (August 15, 2015, May 12, 2022). was queried US reports using Medical Dictionary Regulatory Activities Search Strategy Version 21.1. Preferred Term (PT) “Product use unapproved indication.” PT selected as an indication US. Reports filtered identify exclude non-postmenopausal usages, such males non-HSDD conditions. All stating are included analysis. If reproductive status not specified, age used indicator. unknown, report excluded. range 51-75 years. Adverse categorized PTs, descriptive statistics summarize results. Dispensing data sample 30,000 scripts filled over past year at one pharmacy estimate percentage prescriptions by ages >50 No incidence calculated AE reporting voluntary true exposure unknown. Results We identified 195 unique least period. There 656 AEs, 16 (2.4%) serious, no fatalities. occurring ≥5 excluding related body system summarized Figure. Approximately 18% It important acknowledge pharmacy’s findings may represent all pharmacies. Conclusions observed trials. Excluding PTs drug ineffective, dizziness, nausea, insomnia. signals specific have been date. Although informative, lack information on medical history, concomitant medications, other potential interacting products limit ability make inferences causality cases. Disclosure Yes, sponsored industry/sponsor: Sprout Pharmaceuticals, Inc Clarification: Industry initiated, executed funded Any authors act consultant, employee or shareholder industry for: Inc.