Background:
Flibanserin, a
5-hydroxytryptamine 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 assessed pooled efficacy and safety data for
flibanserin in premenopausal women with HSDD. Materials and Methods: Data for
flibanserin 100 mg once daily at bedtime (qhs) and placebo were pooled from three pivotal 24-week, randomized, placebo-controlled, multicenter studies (VIOLET, DAISY, and BEGONIA) of premenopausal women with HSDD. Pooled efficacy endpoints included the change from baseline to study end (i.e., 24 weeks) in the number of satisfying sexual events (SSEs) over 28 days, the Female Sexual Function Index desire domain (FSFI-d) score, and the Female Sexual Distress Scale-Revised Item 13 (FSDS-R-13) score. Results: The analysis included 2465 women (
flibanserin, n = 1227; placebo, n = 1238) with a mean age of 36 years and a mean HSDD duration of 56.5 months. The mean ± standard error (SE) change from baseline to study end in SSEs over 28 days for
flibanserin versus placebo was 2.1 ± 0.14 versus 1.2 ± 0.11, respectively (p < 0.0001). The least-squares mean ± SE changes from baseline to study end in FSFI desire domain score and FSDS-R-13 score were also significantly greater for
flibanserin versus placebo (FSFI desire domain: 0.9 ± 0.04 vs. 0.6 ± 0.04, p < 0.0001; FSDS-R-13: -0.9 ± 0.04 vs. -0.6 ± 0.04, p < 0.0001). Patients in the
flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics. Adverse events occurring in ≥10% of patients included
dizziness and
somnolence. Conclusions: This pooled analysis of three pivotal trials demonstrated that
flibanserin 100 mg qhs was well tolerated, improved sexual desire, and reduced sexual distress associated with HSDD in premenopausal women, and these improvements were generally consistent across various subgroups based on demographic and baseline characteristics.