144 Safety of Flibanserin in Women With Hypoactive Sexual Desire Disorder Taking Antidepressant Medications

Abstract

Flibanserin is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis evaluated the safety of flibanserin in women taking antidepressant medications. To evaluate the safety of flibanserin in women with acquired, generalized HSDD who reported the use of antidepressant medications that increase serotonergic activity during Phase 3 clinical trials. Data from 8 randomized, double-blind, placebo-controlled studies of flibanserin in HSDD (premenopausal women, protocol violators from 5 studies and patients treated for depression in 1 study; postmenopausal women, protocol violators from 2 studies) were pooled for patients receiving flibanserin 100 mg at bedtime or placebo. This analysis evaluated patients taking a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) at study baseline. The analysis population included 2379 flibanserin-treated (SSRI/SNRI users, n=131) and 2690 placebo-treated (SSRI/SNRI users, n=91) patients. Incidence of adverse events (AEs) in flibanserin-treated patients was 73.3% of SSRI/SNRI users and 65.4% of nonusers; incidence in placebo-treated patients was 79.1% and 54.9%, respectively. Serious AEs in SSRI/SNRI users vs nonusers occurred in 1.5% vs 1.1% of flibanserin-treated patients, respectively, and 0.0% vs 0.7% of placebo-treated patients, respectively. AEs led to treatment discontinuation in 15.3% of SSRI/SNRI users and 11.2% of nonusers who received flibanserin, and 18.7% of users and 5.3% of nonusers who received placebo. The most common AEs in flibanserin-treated patients (overall incidence ≥10%) were dizziness (6.9% of SSRI/SNRI users vs 10.5% of nonusers) and somnolence (6.1% vs 10.4%, respectively).