015 Efficacy of Flibanserin by Duration of Hypoactive Sexual Desire Disorder in Premenopausal Women

Abstract

Flibanserin, a 5-HT1A agonist and 5-HT2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis evaluated the efficacy of flibanserin treatment by duration of HSDD. Data were pooled from three 24-week, double-blind, placebo-controlled studies of flibanserin in premenopausal women with HSDD. Patients were stratified by HSDD duration (>6 months to 2 years, >2-5 years, and >5 years). Key measures of efficacy were the Female Sexual Function Index desire domain (FSFI-d) score, the Female Sexual Distress Scale-Revised item 13 (distress due to low desire; FSDS-R-13) score, and the number of satisfying sexual events (SSE). This analysis included 2344 premenopausal women (HSDD duration >6 months to 2 years, n=705; duration >2-5 years, n=830; duration >5 years, n=809) who received flibanserin 100 mg qhs or placebo. Improvement from baseline to week 24 in FSFI-d score (least-squares [LS] mean change) was significantly greater for flibanserin compared with placebo in women with HSDD for >6 months to 2 years (1.0 vs 0.8; P=0.010), >2-5 years (0.9 vs 0.6; P=0.004), and >5 years (0.9 vs 0.5; P<0.0001). Similarly, significantly greater improvement on the FSDS-R-13 (LS mean change) for flibanserin versus placebo was observed in women with HSDD duration of >6 months to 2 years (-1.0 vs -0.7; P=0.017), >2-5 years (-0.8 vs -0.6; P=0.027), and >5 years (-0.8 vs -0.5; P<0.0001) For SSE, improvement (LS mean change) with flibanserin relative to placebo was significantly different for HSDD duration >6 months to 2 years (2.7 vs 1.6; P=0.018) and duration >5 years (1.9 vs 1.2, P=0.003), but did not reach statistical significance, though trended, for duration of >2-5 years (1.9 vs 1.3; P=0.053). The most common adverse events associated with flibanserin (>5% of flibanserin-treated patients, overall) were somnolence (12.8% for flibanserin vs 3.4% for placebo) and dizziness (10.6% vs 1.5%).