Question the study addresses: Is flibanserin 50 mg or 100 mg taken at bedtime (qhs) safe and effective for treating premenopausal women with acquired, generalized HSDD? Does flibanserin lead to a clinically meaningful treatment response?
How the study was conducted: This study was a pivotal trial used to support the approval of ADDYI in the US and Canada. This 6-month randomized, multicenter, placebo-controlled study of North American premenopausal women with acquired, generalized HSDD evaluated the safety and efficacy of flibanserin 50 mg (n=295) and 100 mg qhs (n=290) compared to placebo (n=295). Safety was assessed by monitoring adverse events (AEs), and efficacy was measured by the number of satisfying sexual events (SSEs), sexual desire (eDiary daily scores) and FSFI desire domain scores, and associated distress (FSDS-R Item 13) at predefined study visits starting at Week 4. In addition, clinically meaningful treatment response was assessed using a single question that asked women to rate their level of improvement at the end of the study.
Answer based on study finding: Flibanserin 50 mg and 100 mg qhs for six months was generally safe, with no significant safety concerns. Most frequently reported AEs associated with flibanserin, occurring at a higher incidence with flibanserin 100 mg, were related to CNS depression and nausea. Treatment with flibanserin 50 mg and 100 mg was effective at significantly increasing the number of SSEs, level of sexual desire (FSFI-desire domain scores every 4 weeks), and significantly decreasing associated distress compared to placebo. These improvements were considered clinically meaningful in significantly more flibanserin-treated women. However, when sexual desire was measured daily using the eDiary, treatment with flibanserin did not result in statistically significant improvements compared to placebo.
