Treatment of hypoactive sexual desire disorder in premenopausal women: Efficacy of flibanserin in the DAISY study

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Question the study addresses: Are various doses of flibanserin 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 various flibanserin doses (25 mg twice a day [n=396], 50 mg bid [n=392], 100 mg qhs [n=395]) compared to placebo [n=398]. 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: Across various doses, flibanserin was generally well tolerated with no significant safety concerns. The most frequently reported AEs associated with flibanserin included somnolence, dizziness, and fatigue. The highest incidence of AEs occurred with flibanserin 50 mg bid. Compared to placebo, significant increases in SSEs occurred only in the flibanserin 100 mg qhs dose. No flibanserin dose resulted in significant increases in eDiary daily desire scores compared to placebo. However, when desire was captured using FSFI desire domain scores, all flibanserin doses resulted in a significant increase in desire compared to placebo. In addition, associated distress was significantly decreased in all flibanserin groups compared to placebo. These improvements were considered clinically meaningful in significantly more flibanserin-treated women.

Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial

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Question the study addresses: Is flibanserin 100 mg qhs safe and effective for treating naturally postmenopausal women with acquired, generalized HSDD?

How the study was conducted: This study was a Phase 3 safety and efficacy trial used to support the approval of ADDYI in postmenopausal women in Canada. This 6-month randomized, placebo-controlled study of North American naturally postmenopausal women with acquired, generalized HSDD evaluated the safety and efficacy of flibanserin 100 mg qhs (n=468) compared to placebo (n=481). Safety was assessed by monitoring adverse events, 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 100 mg qhs for six months was generally safe, with no significant safety concerns. The most frequently reported adverse events associated with flibanserin were CNS depression (dizziness, somnolence), nausea and headache. Treatment with flibanserin was associated with statistically significant increases in sexual desire and number of SSEs, and reduced associated distress, compared to placebo. Significantly more flibanserin-treated women reported clinically meaningful improvements at the end of the study compared to placebo.

Efficacy of flibanserin in women with hypoactive sexual desire disorder: Results from the BEGONIA trial

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Question the study addresses: Is flibanserin 100 mg taken once a day at bedtime 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 the third and final pivotal trial used to support the approval of ADDYI for premenopausal use 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 100 mg once a day at bedtime (qhs) (n=543) compared to placebo (n=547). Safety was assessed by monitoring adverse events (AEs), and efficacy was measured by the number of satisfying sexual events (SSEs), sexual desire (FSFI scores), and associated distress (FSDS-R Item 13) at predefined study visits starting at Week 4. 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: This study found that in premenopausal women with acquired, generalized HSDD treatment with flibanserin 100 mg qhs for six months was generally safe, with no significant safety concerns. Most frequently reported AEs associated with flibanserin were related to CNS depression and nausea. In addition, compared to placebo, treatment with flibanserin was effective at significantly increasing the number of SSEs and level of sexual desire (FSFI-desire domain scores every 4 weeks) and significantly decreasing associated distress compared to placebo, and these improvements were rated as clinically meaningful in significantly more flibanserin treated women.