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Publications: This section contains educational resources on information relating to Addyi (Flibanserin 100mg).
Efficacy of flibanserin in women with hypoactive sexual desire disorder: Results from the BEGONIA trial
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.
Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial
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.
Treatment of hypoactive sexual desire disorder in premenopausal women: Efficacy of flibanserin in the DAISY study
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.
Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the VIOLET Study.
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.
Open-label extension study of flibanserin in women with hypoactive sexual desire disorder
Open-label extension study of flibanserin in women with hypoactive sexual desire disorderIntroduction: Hypoactive Sexual Desire Disorder (HSDD) is a common form of Female Sexual Dysfunction characterized by low sexual desire that causes distress or interpersonal difficulty. Aim: This 52-week open-label extension study aimed to assess the safety and tolerability of flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A)…
Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): results from a randomized withdrawal trial
Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): results from a randomized withdrawal trialIntroduction: Flibanserin is a 5-HT(1A) agonist/5-HT(2A) antagonist that has been shown to increase sexual desire and reduce distress in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD). Aim: To assess the efficacy and safety of…
Flibanserin for hypoactive sexual desire disorder: an open-label safety study
Flibanserin for hypoactive sexual desire disorder: an open-label safety studyBackground: To evaluate the safety of flibanserin in premenopausal and naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) in an open-label extension (OLE) study. Aim: To examine the safety and tolerability of flibanserin 100 mg once daily at bedtime in the treatment of premenopausal and…
Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder
Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorderIntroduction: Flibanserin is a novel pharmacologic agent in late-stage clinical testing for hypoactive sexual desire disorder (HSDD) in premenopausal women. Aim: The aim of this article is to review the hypothetical mechanism of action of flibanserin in HSDD. Methods: A literature review…
Mechanism of action of flibanserin, a multifunctional serotonin agonist and antagonist (MSAA), in hypoactive sexual desire disorder
Mechanism of action of flibanserin, a multifunctional serotonin agonist and antagonist (MSAA), in hypoactive sexual desire disorderAbstract: Flibanserin is a novel multifunctional serotonin agonist and antagonist (MSAA) that improves sexual functioning in premenopausal women who suffer from reduced sexual interest and desire.
Publications: This contains educational resources on information relating to Addyi (Flibanserin).
Efficacy of flibanserin in women with hypoactive sexual desire disorder: Results from the BEGONIA trial
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.
Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial
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.
Treatment of hypoactive sexual desire disorder in premenopausal women: Efficacy of flibanserin in the DAISY study
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.
Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the VIOLET Study.
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.
Open-label extension study of flibanserin in women with hypoactive sexual desire disorder
Open-label extension study of flibanserin in women with hypoactive sexual desire disorderIntroduction: Hypoactive Sexual Desire Disorder (HSDD) is a common form of Female Sexual Dysfunction characterized by low sexual desire that causes distress or interpersonal difficulty. Aim: This 52-week open-label extension study aimed to assess the safety and tolerability of flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A)…
Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): results from a randomized withdrawal trial
Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): results from a randomized withdrawal trialIntroduction: Flibanserin is a 5-HT(1A) agonist/5-HT(2A) antagonist that has been shown to increase sexual desire and reduce distress in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD). Aim: To assess the efficacy and safety of…
Flibanserin for hypoactive sexual desire disorder: an open-label safety study
Flibanserin for hypoactive sexual desire disorder: an open-label safety studyBackground: To evaluate the safety of flibanserin in premenopausal and naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) in an open-label extension (OLE) study. Aim: To examine the safety and tolerability of flibanserin 100 mg once daily at bedtime in the treatment of premenopausal and…
Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder
Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorderIntroduction: Flibanserin is a novel pharmacologic agent in late-stage clinical testing for hypoactive sexual desire disorder (HSDD) in premenopausal women. Aim: The aim of this article is to review the hypothetical mechanism of action of flibanserin in HSDD. Methods: A literature review…
Mechanism of action of flibanserin, a multifunctional serotonin agonist and antagonist (MSAA), in hypoactive sexual desire disorder
Mechanism of action of flibanserin, a multifunctional serotonin agonist and antagonist (MSAA), in hypoactive sexual desire disorderAbstract: Flibanserin is a novel multifunctional serotonin agonist and antagonist (MSAA) that improves sexual functioning in premenopausal women who suffer from reduced sexual interest and desire.