Boehringer Ingelheim’s flibanserin boosts sexual desire in women with HSDD
Ingelheim/Ridgefield – Boehringer Ingelheim has presented promising Phase III results demonstrating that its drug candidate flibanserin significantly increases satisfying sexual events (SSE) and sexual desire in pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD) compared to placebo. HSDD is a persistent or recurrent decrease or lack of sexual desire that causes distress for the patient, may put a strain on relationships with partners, and is not due to the effects of a substance, including medications, or another medical condition. The findings, presented at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco, include data from a pre-specified pooled analysis of two pivotal North American trials (DAISY and VIOLET). According to the pooled analysis of 1,378 pre-menopausal women by 24 weeks, 48.3 percent of women receiving flibanserin and 30.3 percent of women receiving placebo reported feeling very much improved, much improved or minimally improved (p<0.0001). A second pooled analysis included 971 (flibanserin 100 mg qhs: 450; placebo: 521) pre-menopausal women who completed the 24-week trials. In that analysis, flibanserin 100mg significantly increased the frequency of satisfying sexual events versus placebo (increase of 2.1 events vs. 0.9 events, respectively; p < 0.0001) over the study period. The analysis also found that, compared with placebo, flibanserin 100 mg showed statically significant improved measures of sexual desire using an electronic daily diary or eDiary (primary endpoint) and on the Female Sexual Function Index (FSFI) desire domain (secondary endpoint). Compared with placebo, flibanserin also showed statistically significant improved sexual functioning (as measured by the FSFI total score), and distress related to low sexual desire (based on the Female Sexual Distress Scale-Revised, FSDS-R, total score), which were secondary endpoints.