021 Flibanserin in Premenopausal Women With Hypoactive Sexual Desire Disorder: Pooled Analysis of Safety From Phase 3, Placebo-Controlled Studies

Abstract

Flibanserin, a 5-HT1A agonist and 5-HT2A antagonist, is approved for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This analysis evaluated the incidence of most common adverse events (AEs) with flibanserin 100 mg in premenopausal women with HSDD. Patient-level data from five 24-week, randomized, double-blind, placebo-controlled, phase 3 studies were pooled. The incidence, severity, time to first onset, and duration of AEs with flibanserin 100 mg taken at bedtime (qhs) and placebo treatment were evaluated. All randomly assigned patients who received ≥1 dose of flibanserin 100 mg qhs (N=1543) or placebo (N=1905) were included. Most patients (88.2%) were white; mean age was 35.8 years. Mean exposure was 139.0 days with flibanserin and 147.4 days with placebo. The most common AEs (≥2% of flibanserin-treated patients and at ≥ twice the rate for placebo) were dizziness (11.4% for flibanserin vs 2.2% for placebo), somnolence (11.2% vs 3.1%), nausea (10.4% vs 3.7%), insomnia (4.9% vs 2.4%), and dry mouth (2.4% vs 0.9%). Hypotension (0.2% vs 0.0%) and syncope (0.3% vs 0.1%) were infrequent. Incidences of common AEs were generally reported as being of mild intensity. Severe AEs were experienced by 6.9% of patients receiving flibanserin and 4.7% of patients receiving placebo. Onset of common AEs typically occurred within the first week of therapy: median time to first onset of dizziness was 5.5 vs 5.0 days with flibanserin vs placebo, respectively; somnolence was 2.0 days for both treatments; nausea was 5.0 vs 8.0 days, insomnia was 11.0 vs 3.0 days; and dry mouth was 7.0 vs 8.0 days. Median duration of dizziness was 11 vs 10 days with flibanserin vs placebo, respectively; somnolence was 37 vs 35 days; nausea was 5 days for both treatments; insomnia was 31 vs 16 days; and dry mouth was 26 vs 61 days. AEs led to treatment discontinuation in 12.8% of patients receiving flibanserin and 5.9% of patients receiving placebo.