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James A Simon - One of the best experts on this subject based on the ideXlab platform.
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effects of alcohol administered with Flibanserin in healthy premenopausal women a randomized double blind single dose crossover study
The Journal of Sexual Medicine, 2019Co-Authors: James A Simon, Anita H Clayton, Sharon J Parish, Stuart C Apfel, Leah MillheiserAbstract:Abstract Introduction Flibanserin is approved in the United States and Canada for the treatment of hypoactive sexual desire disorder in premenopausal women. Aim The purpose of this trial was to evaluate the safety of concomitant administration of Flibanserin with alcohol. Methods In this single-center, randomized, double-blind, single-dose, crossover study, participants were randomly assigned to 1 of 12 sequences to receive each of 7 treatments: Flibanserin 100 mg or placebo with ethanol 0.2 g/kg, 0.4 g/kg, or 0.6 g/kg, or Flibanserin 100 mg only. Treatments were administered using a worst-case approach that included morning dosing and consumption of alcohol within 10 minutes. Main Outcome Measure The primary end point was the proportion of participants who experienced dizziness, syncope, or hypotension. Safety end points included orthostatic vital signs. Results The study included 96 premenopausal women (mean age 31 ± 8 years). The incidence of dizziness for ethanol + Flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for Flibanserin without ethanol. Based on the available vital signs data, there was no effect of ethanol concentration on orthostatic blood pressure, vertigo, or hypotension; no instances of syncope were observed. The overall incidence of adverse events (AEs) was similar when Flibanserin was administered alone (96.7%) or with ethanol (90.5–97.6%). Clinical Implications Consumption of the tested amounts of alcohol (0.2–0.6 g/kg) does not have an additive effect on the AE profile of Flibanserin 100 mg in healthy premenopausal women. Strengths & Limitations Strengths include the study population (premenopausal women, as indicated for Flibanserin) and range of ethanol doses. Limitations include the morning dosing of study medication, which is inconsistent with the bedtime dosing recommended for Flibanserin, and the method of handling missing vital sign measurements. Conclusion Co-administration of Flibanserin 100 mg with varying doses of ethanol resulted in few AEs of special interest, with no notable alcohol dose response. However, a significantly greater percentage of participants administered Flibanserin with 0.6 g/kg and 0.4 g/kg of alcohol were characterized as “Participants in Whom Standing Blood Pressure Was Not Obtained” compared with participants administered Flibanserin alone. Simon JA, Clayton AH, Parish SJ, et al. Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study. J Sex Med 2020;17:83–93.
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effects of timing of Flibanserin administration relative to alcohol intake in healthy premenopausal women a randomized double blind crossover study
The Journal of Sexual Medicine, 2019Co-Authors: James A Simon, Sheryl A Kingsberg, Noel N Kim, Anita H Clayton, Sharon J Parish, Leah MillheiserAbstract:Abstract Introduction Flibanserin is approved in the United States and Canada for the treatment of acquired, generalized, hypoactive sexual desire disorder in premenopausal women. Sedation-related side effects are among the most prevalent adverse events. Although infrequent, hypotension and syncope remain safety concerns because of possible interaction of Flibanserin with alcohol. Aim To evaluate the impact of the timing of alcohol consumption on Flibanserin safety and tolerability. Methods In this single-center, randomized, double-blind, placebo-controlled, 4-treatment crossover study, 64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years) received once-daily Flibanserin 100 mg or placebo during each of two 10-day treatment periods. Study medication was administered on days 1–3 to achieve steady state. On days 4, 6, 8, and 10, after a standard breakfast, participants consumed 0.4 g/kg ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol) 2 hours before taking study medication. Outcomes The primary endpoint was percentage of participants experiencing syncope or orthostatic hypotension–associated adverse events requiring medical intervention. Secondary endpoints included the incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence). Results 1 participant experienced a primary endpoint event (syncope) during treatment with placebo taken 4 hours after ethanol consumption. Within each ethanol dose–timing treatment, there were no statistically significant differences for Flibanserin compared with placebo. Rates of hypotension were 53.3–66.7% after Flibanserin dosing and 57.4–63.3% after placebo dosing. Rates for orthostatic hypotension were 0.0–5.0% after Flibanserin dosing and 1.7–6.6% after placebo dosing. Clinical Implications Ethanol interaction with Flibanserin was not observed in this study. Strengths & Limitations This study provides information regarding the use of Flibanserin after the consumption of moderate amounts of ethanol (0.4 g/kg). However, daytime administration of Flibanserin is not consistent with the drug’s indicated bedtime dosing. Conclusion Flibanserin, at steady state taken 2, 4, or 6 hours after 0.4 g/kg of ethanol intake did not increase the incidence of hypotension, orthostatic hypotension, or syncope compared with either Flibanserin alone or ethanol alone. Simon JA, Clayton AH, Kingsberg SA, et al. Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. J Sex Med 2019;16:1779–1786.
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weight loss in women taking Flibanserin for hypoactive sexual desire disorder hsdd insights into potential mechanisms
Sexual medicine reviews, 2019Co-Authors: James A Simon, Sheryl A Kingsberg, Irwin Goldstein, Noel N Kim, Brittany Hakim, Leah MillheiserAbstract:Abstract Introduction Flibanserin, a multifunctional serotonin receptor agonist and antagonist, is currently approved in the United States and Canada for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. A post hoc analysis of HSDD clinical trial data found that Flibanserin treatment was associated with statistically significant weight loss relative to placebo, even though study patients were not selected for being overweight/obese and were provided no expectation for weight reduction or interventions intended to promote weight loss. Aim To understand possible mechanisms by which Flibanserin may produce weight loss. Methods A literature review was performed using Medline database for relevant publications on the mechanisms of action by which Flibanserin may provide weight loss and the links between sexual function and weight management. Main Outcome Measures Examination of (i) biopsychosocial factors regulating sexual desire, food intake, and weight regulation; (ii) clinical pharmacology of Flibanserin; (iii) neurobiology of brain reward circuitry; and (iv) identification of possible mechanisms common to Flibanserin and weight loss. Results Based on Flibanserin clinical trial data, there was no consistent correlation between weight loss and improvement in sexual function, as assessed by HSDD outcome measures. Nausea, a common adverse event associated with Flibanserin use, also did not appear to be a contributing factor to weight loss. Hypothetical links between Flibanserin treatment and weight loss include modulation of peripheral 5-HT2A receptors and factors such as improved mood and improved sleep. Conclusion Mechanisms of Flibanserin-induced weight loss have not been well characterized but may involve indirect beneficial effects on peripheral 5-HT2A receptors and central regulation of mood and sleep. Future research may better elucidate the links between sexual function and weight management and the mechanism(s) by which Flibanserin use may result in weight loss. Simon JA, Kingsberg SA, Goldstein I, et al. Weight Loss in Women Taking Flibanserin for Hypoactive Sexual Desire Disorder (HSDD): Insights into Potential Mechanisms. Sex Med Rev 2019;7:575–586.
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safety and tolerability of evening ethanol consumption and bedtime administration of Flibanserin in healthy premenopausal female subjects
Sexual Medicine, 2019Co-Authors: Leah Millheiser, Sheryl A Kingsberg, Noel N Kim, Anita H Clayton, Sharon J Parish, James A SimonAbstract:Abstract Introduction Flibanserin, a treatment for hypoactive sexual desire disorder, carries warnings for increased risk of severe hypotension and syncope when used with alcohol. However, these warnings are not informed by studies that used Flibanserin’s recommended bedtime dosing because previous alcohol studies assessed Flibanserin’s safety during the day. Aim The aim of this study was to assess the effects of ethanol in a real-world context in premenopausal women taking Flibanserin at bedtime. Methods In a randomized, placebo-controlled, double-blind study, 24 healthy premenopausal women (mean age = 34.5 ± 9.9 years; mean body mass index = 25.2 ± 3.4 kg/m2) were dosed with Flibanserin or placebo for 3 days to achieve steady-state plasma levels. In a clinical research unit, subjects (n = 22) were provided 2 units of wine (150 mL/unit; 12% ethanol content) or a nonalcoholic beverage with a standardized 3-course evening meal. Flibanserin 100 mg or placebo was administered at bedtime 2.5 hours after the end of the evening meal. On a separate day, subjects were provided the alternative beverage (± alcohol) with the same evening meal and dosed with the same treatment (Flibanserin or placebo) at bedtime. After a 5-day washout period, subjects crossed over to the other treatment arm and the protocol was repeated. Main Outcome Measure Adverse events (AEs) and vital signs were monitored. Results In the absence of ethanol, headaches and hypotension were the only AEs that occurred in ≥2 subjects after Flibanserin dosing (placebo corrected rates were 17.4% and 8.7%, respectively). After ethanol consumption, the rate of hypotension after Flibanserin dosing was no greater than with Flibanserin or placebo after nonalcoholic beverage consumption. There were no instances of orthostatic hypotension or syncope and no serious AEs or AEs leading to study discontinuation. Conclusion Flibanserin dosed at bedtime after moderate amounts of alcohol with an evening meal was well-tolerated with no evidence of clinically significant hypotension or syncope. Millheiser L, Clayton AH, Parish SJ, et al. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med 2019;7:418–424.
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Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials.
Journal of women's health (2002), 2019Co-Authors: James A Simon, John M Thorp, Leah MillheiserAbstract:Abstract 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 pre...
Anita H Clayton - One of the best experts on this subject based on the ideXlab platform.
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evaluation of safety for Flibanserin
Expert Opinion on Drug Safety, 2020Co-Authors: Anita H Clayton, Louise Brown, Noel N KimAbstract:Introduction: Hypoactive sexual desire disorder (HSDD) is the most prevalent sexual dysfunction in women, previously managed with off-label therapies. Indicated for premenopausal women, Flibanserin is the first FDA-approved medication to treat HSDD.Areas covered: This review summarizes Flibanserin's pharmacokinetics, proposed mechanism of action, and safety data in clinical trials with a focus on sedation- and hypotension-related adverse events, and drug interactions with alcohol and antidepressants. Sources included peer-reviewed publications and internal data from the manufacturer.Expert opinion: Flibanserin is a well-tolerated and effective treatment that decreases distress and restores sexual desire to a level that is normative for the individual patient with HSDD. Simplification of a risk mitigation program for Flibanserin in the US is likely to increase the number of prescribing clinicians if accompanied with educational efforts to clarify Flibanserin's risk-benefit profile. As Flibanserin is dosed daily and may be used for a decade or more in the typical premenopausal patient, long-term pharmacovigilance data will be essential. Over time, HSDD will be treated by more nonspecialist health care professionals and Flibanserin will likely become established as a significant treatment option along with other medications approved for this indication in the context of a holistic biopsychosocial treatment paradigm.
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effects of alcohol administered with Flibanserin in healthy premenopausal women a randomized double blind single dose crossover study
The Journal of Sexual Medicine, 2019Co-Authors: James A Simon, Anita H Clayton, Sharon J Parish, Stuart C Apfel, Leah MillheiserAbstract:Abstract Introduction Flibanserin is approved in the United States and Canada for the treatment of hypoactive sexual desire disorder in premenopausal women. Aim The purpose of this trial was to evaluate the safety of concomitant administration of Flibanserin with alcohol. Methods In this single-center, randomized, double-blind, single-dose, crossover study, participants were randomly assigned to 1 of 12 sequences to receive each of 7 treatments: Flibanserin 100 mg or placebo with ethanol 0.2 g/kg, 0.4 g/kg, or 0.6 g/kg, or Flibanserin 100 mg only. Treatments were administered using a worst-case approach that included morning dosing and consumption of alcohol within 10 minutes. Main Outcome Measure The primary end point was the proportion of participants who experienced dizziness, syncope, or hypotension. Safety end points included orthostatic vital signs. Results The study included 96 premenopausal women (mean age 31 ± 8 years). The incidence of dizziness for ethanol + Flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for Flibanserin without ethanol. Based on the available vital signs data, there was no effect of ethanol concentration on orthostatic blood pressure, vertigo, or hypotension; no instances of syncope were observed. The overall incidence of adverse events (AEs) was similar when Flibanserin was administered alone (96.7%) or with ethanol (90.5–97.6%). Clinical Implications Consumption of the tested amounts of alcohol (0.2–0.6 g/kg) does not have an additive effect on the AE profile of Flibanserin 100 mg in healthy premenopausal women. Strengths & Limitations Strengths include the study population (premenopausal women, as indicated for Flibanserin) and range of ethanol doses. Limitations include the morning dosing of study medication, which is inconsistent with the bedtime dosing recommended for Flibanserin, and the method of handling missing vital sign measurements. Conclusion Co-administration of Flibanserin 100 mg with varying doses of ethanol resulted in few AEs of special interest, with no notable alcohol dose response. However, a significantly greater percentage of participants administered Flibanserin with 0.6 g/kg and 0.4 g/kg of alcohol were characterized as “Participants in Whom Standing Blood Pressure Was Not Obtained” compared with participants administered Flibanserin alone. Simon JA, Clayton AH, Parish SJ, et al. Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study. J Sex Med 2020;17:83–93.
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effects of timing of Flibanserin administration relative to alcohol intake in healthy premenopausal women a randomized double blind crossover study
The Journal of Sexual Medicine, 2019Co-Authors: James A Simon, Sheryl A Kingsberg, Noel N Kim, Anita H Clayton, Sharon J Parish, Leah MillheiserAbstract:Abstract Introduction Flibanserin is approved in the United States and Canada for the treatment of acquired, generalized, hypoactive sexual desire disorder in premenopausal women. Sedation-related side effects are among the most prevalent adverse events. Although infrequent, hypotension and syncope remain safety concerns because of possible interaction of Flibanserin with alcohol. Aim To evaluate the impact of the timing of alcohol consumption on Flibanserin safety and tolerability. Methods In this single-center, randomized, double-blind, placebo-controlled, 4-treatment crossover study, 64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years) received once-daily Flibanserin 100 mg or placebo during each of two 10-day treatment periods. Study medication was administered on days 1–3 to achieve steady state. On days 4, 6, 8, and 10, after a standard breakfast, participants consumed 0.4 g/kg ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol) 2 hours before taking study medication. Outcomes The primary endpoint was percentage of participants experiencing syncope or orthostatic hypotension–associated adverse events requiring medical intervention. Secondary endpoints included the incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence). Results 1 participant experienced a primary endpoint event (syncope) during treatment with placebo taken 4 hours after ethanol consumption. Within each ethanol dose–timing treatment, there were no statistically significant differences for Flibanserin compared with placebo. Rates of hypotension were 53.3–66.7% after Flibanserin dosing and 57.4–63.3% after placebo dosing. Rates for orthostatic hypotension were 0.0–5.0% after Flibanserin dosing and 1.7–6.6% after placebo dosing. Clinical Implications Ethanol interaction with Flibanserin was not observed in this study. Strengths & Limitations This study provides information regarding the use of Flibanserin after the consumption of moderate amounts of ethanol (0.4 g/kg). However, daytime administration of Flibanserin is not consistent with the drug’s indicated bedtime dosing. Conclusion Flibanserin, at steady state taken 2, 4, or 6 hours after 0.4 g/kg of ethanol intake did not increase the incidence of hypotension, orthostatic hypotension, or syncope compared with either Flibanserin alone or ethanol alone. Simon JA, Clayton AH, Kingsberg SA, et al. Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. J Sex Med 2019;16:1779–1786.
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safety and tolerability of evening ethanol consumption and bedtime administration of Flibanserin in healthy premenopausal female subjects
Sexual Medicine, 2019Co-Authors: Leah Millheiser, Sheryl A Kingsberg, Noel N Kim, Anita H Clayton, Sharon J Parish, James A SimonAbstract:Abstract Introduction Flibanserin, a treatment for hypoactive sexual desire disorder, carries warnings for increased risk of severe hypotension and syncope when used with alcohol. However, these warnings are not informed by studies that used Flibanserin’s recommended bedtime dosing because previous alcohol studies assessed Flibanserin’s safety during the day. Aim The aim of this study was to assess the effects of ethanol in a real-world context in premenopausal women taking Flibanserin at bedtime. Methods In a randomized, placebo-controlled, double-blind study, 24 healthy premenopausal women (mean age = 34.5 ± 9.9 years; mean body mass index = 25.2 ± 3.4 kg/m2) were dosed with Flibanserin or placebo for 3 days to achieve steady-state plasma levels. In a clinical research unit, subjects (n = 22) were provided 2 units of wine (150 mL/unit; 12% ethanol content) or a nonalcoholic beverage with a standardized 3-course evening meal. Flibanserin 100 mg or placebo was administered at bedtime 2.5 hours after the end of the evening meal. On a separate day, subjects were provided the alternative beverage (± alcohol) with the same evening meal and dosed with the same treatment (Flibanserin or placebo) at bedtime. After a 5-day washout period, subjects crossed over to the other treatment arm and the protocol was repeated. Main Outcome Measure Adverse events (AEs) and vital signs were monitored. Results In the absence of ethanol, headaches and hypotension were the only AEs that occurred in ≥2 subjects after Flibanserin dosing (placebo corrected rates were 17.4% and 8.7%, respectively). After ethanol consumption, the rate of hypotension after Flibanserin dosing was no greater than with Flibanserin or placebo after nonalcoholic beverage consumption. There were no instances of orthostatic hypotension or syncope and no serious AEs or AEs leading to study discontinuation. Conclusion Flibanserin dosed at bedtime after moderate amounts of alcohol with an evening meal was well-tolerated with no evidence of clinically significant hypotension or syncope. Millheiser L, Clayton AH, Parish SJ, et al. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med 2019;7:418–424.
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evaluation of Flibanserin safety comparison with other serotonergic medications
Sexual medicine reviews, 2019Co-Authors: Sheryl A Kingsberg, Susan L Mcelroy, Anita H ClaytonAbstract:Abstract Introduction Flibanserin, a multifunctional serotonin agonist and antagonist, is approved by the U.S. Food and Drug Administration (FDA) for treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women. During the FDA’s review of Flibanserin, concerns were raised about the risks of hypotension, syncope, and sedation-related adverse events, which increase with alcohol use. Based on the results of an alcohol challenge study, the FDA required a boxed warning and alcohol contraindication in the Flibanserin prescribing information, as part of a risk evaluation and mitigation strategy program. Aim To evaluate the adverse event profile of Flibanserin in the context of that seen with other medications that affect serotonin in the brain and are commonly prescribed for women. Methods This was a review of data provided in the product prescribing information for Flibanserin, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, other serotonergic antidepressants, and triptans. Main Outcome Measures The incidence of adverse events was assessed. Results The incidences of hypotension, syncope, and sedation-related adverse events (eg, dizziness, somnolence, fatigue) in studies of Flibanserin were within the ranges observed for serotonergic antidepressants; the rates of these adverse events were generally lower with triptan medications. Other Flibanserin-associated adverse events (eg, nausea, insomnia, dry mouth) occurred more commonly in patients taking antidepressant medications. Conclusion Although medications that affect the serotonin system have varying adverse event profiles (likely mediated by differences in serotonin-related mechanisms of action, specific brain structures affected, and effects on other neurotransmitter systems), the occurrence of central nervous system–related adverse events was not dissimilar between Flibanserin and serotonergic antidepressants. Kingsberg SA, McElroy SL, Clayton AH. Evaluation of Flibanserin Safety: Comparison with Other Serotonergic Medications. Sex Med Rev 2019;7:380–392.
Sheryl A Kingsberg - One of the best experts on this subject based on the ideXlab platform.
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effects of timing of Flibanserin administration relative to alcohol intake in healthy premenopausal women a randomized double blind crossover study
The Journal of Sexual Medicine, 2019Co-Authors: James A Simon, Sheryl A Kingsberg, Noel N Kim, Anita H Clayton, Sharon J Parish, Leah MillheiserAbstract:Abstract Introduction Flibanserin is approved in the United States and Canada for the treatment of acquired, generalized, hypoactive sexual desire disorder in premenopausal women. Sedation-related side effects are among the most prevalent adverse events. Although infrequent, hypotension and syncope remain safety concerns because of possible interaction of Flibanserin with alcohol. Aim To evaluate the impact of the timing of alcohol consumption on Flibanserin safety and tolerability. Methods In this single-center, randomized, double-blind, placebo-controlled, 4-treatment crossover study, 64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years) received once-daily Flibanserin 100 mg or placebo during each of two 10-day treatment periods. Study medication was administered on days 1–3 to achieve steady state. On days 4, 6, 8, and 10, after a standard breakfast, participants consumed 0.4 g/kg ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol) 2 hours before taking study medication. Outcomes The primary endpoint was percentage of participants experiencing syncope or orthostatic hypotension–associated adverse events requiring medical intervention. Secondary endpoints included the incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence). Results 1 participant experienced a primary endpoint event (syncope) during treatment with placebo taken 4 hours after ethanol consumption. Within each ethanol dose–timing treatment, there were no statistically significant differences for Flibanserin compared with placebo. Rates of hypotension were 53.3–66.7% after Flibanserin dosing and 57.4–63.3% after placebo dosing. Rates for orthostatic hypotension were 0.0–5.0% after Flibanserin dosing and 1.7–6.6% after placebo dosing. Clinical Implications Ethanol interaction with Flibanserin was not observed in this study. Strengths & Limitations This study provides information regarding the use of Flibanserin after the consumption of moderate amounts of ethanol (0.4 g/kg). However, daytime administration of Flibanserin is not consistent with the drug’s indicated bedtime dosing. Conclusion Flibanserin, at steady state taken 2, 4, or 6 hours after 0.4 g/kg of ethanol intake did not increase the incidence of hypotension, orthostatic hypotension, or syncope compared with either Flibanserin alone or ethanol alone. Simon JA, Clayton AH, Kingsberg SA, et al. Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. J Sex Med 2019;16:1779–1786.
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weight loss in women taking Flibanserin for hypoactive sexual desire disorder hsdd insights into potential mechanisms
Sexual medicine reviews, 2019Co-Authors: James A Simon, Sheryl A Kingsberg, Irwin Goldstein, Noel N Kim, Brittany Hakim, Leah MillheiserAbstract:Abstract Introduction Flibanserin, a multifunctional serotonin receptor agonist and antagonist, is currently approved in the United States and Canada for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. A post hoc analysis of HSDD clinical trial data found that Flibanserin treatment was associated with statistically significant weight loss relative to placebo, even though study patients were not selected for being overweight/obese and were provided no expectation for weight reduction or interventions intended to promote weight loss. Aim To understand possible mechanisms by which Flibanserin may produce weight loss. Methods A literature review was performed using Medline database for relevant publications on the mechanisms of action by which Flibanserin may provide weight loss and the links between sexual function and weight management. Main Outcome Measures Examination of (i) biopsychosocial factors regulating sexual desire, food intake, and weight regulation; (ii) clinical pharmacology of Flibanserin; (iii) neurobiology of brain reward circuitry; and (iv) identification of possible mechanisms common to Flibanserin and weight loss. Results Based on Flibanserin clinical trial data, there was no consistent correlation between weight loss and improvement in sexual function, as assessed by HSDD outcome measures. Nausea, a common adverse event associated with Flibanserin use, also did not appear to be a contributing factor to weight loss. Hypothetical links between Flibanserin treatment and weight loss include modulation of peripheral 5-HT2A receptors and factors such as improved mood and improved sleep. Conclusion Mechanisms of Flibanserin-induced weight loss have not been well characterized but may involve indirect beneficial effects on peripheral 5-HT2A receptors and central regulation of mood and sleep. Future research may better elucidate the links between sexual function and weight management and the mechanism(s) by which Flibanserin use may result in weight loss. Simon JA, Kingsberg SA, Goldstein I, et al. Weight Loss in Women Taking Flibanserin for Hypoactive Sexual Desire Disorder (HSDD): Insights into Potential Mechanisms. Sex Med Rev 2019;7:575–586.
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safety and tolerability of evening ethanol consumption and bedtime administration of Flibanserin in healthy premenopausal female subjects
Sexual Medicine, 2019Co-Authors: Leah Millheiser, Sheryl A Kingsberg, Noel N Kim, Anita H Clayton, Sharon J Parish, James A SimonAbstract:Abstract Introduction Flibanserin, a treatment for hypoactive sexual desire disorder, carries warnings for increased risk of severe hypotension and syncope when used with alcohol. However, these warnings are not informed by studies that used Flibanserin’s recommended bedtime dosing because previous alcohol studies assessed Flibanserin’s safety during the day. Aim The aim of this study was to assess the effects of ethanol in a real-world context in premenopausal women taking Flibanserin at bedtime. Methods In a randomized, placebo-controlled, double-blind study, 24 healthy premenopausal women (mean age = 34.5 ± 9.9 years; mean body mass index = 25.2 ± 3.4 kg/m2) were dosed with Flibanserin or placebo for 3 days to achieve steady-state plasma levels. In a clinical research unit, subjects (n = 22) were provided 2 units of wine (150 mL/unit; 12% ethanol content) or a nonalcoholic beverage with a standardized 3-course evening meal. Flibanserin 100 mg or placebo was administered at bedtime 2.5 hours after the end of the evening meal. On a separate day, subjects were provided the alternative beverage (± alcohol) with the same evening meal and dosed with the same treatment (Flibanserin or placebo) at bedtime. After a 5-day washout period, subjects crossed over to the other treatment arm and the protocol was repeated. Main Outcome Measure Adverse events (AEs) and vital signs were monitored. Results In the absence of ethanol, headaches and hypotension were the only AEs that occurred in ≥2 subjects after Flibanserin dosing (placebo corrected rates were 17.4% and 8.7%, respectively). After ethanol consumption, the rate of hypotension after Flibanserin dosing was no greater than with Flibanserin or placebo after nonalcoholic beverage consumption. There were no instances of orthostatic hypotension or syncope and no serious AEs or AEs leading to study discontinuation. Conclusion Flibanserin dosed at bedtime after moderate amounts of alcohol with an evening meal was well-tolerated with no evidence of clinically significant hypotension or syncope. Millheiser L, Clayton AH, Parish SJ, et al. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med 2019;7:418–424.
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evaluation of Flibanserin safety comparison with other serotonergic medications
Sexual medicine reviews, 2019Co-Authors: Sheryl A Kingsberg, Susan L Mcelroy, Anita H ClaytonAbstract:Abstract Introduction Flibanserin, a multifunctional serotonin agonist and antagonist, is approved by the U.S. Food and Drug Administration (FDA) for treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women. During the FDA’s review of Flibanserin, concerns were raised about the risks of hypotension, syncope, and sedation-related adverse events, which increase with alcohol use. Based on the results of an alcohol challenge study, the FDA required a boxed warning and alcohol contraindication in the Flibanserin prescribing information, as part of a risk evaluation and mitigation strategy program. Aim To evaluate the adverse event profile of Flibanserin in the context of that seen with other medications that affect serotonin in the brain and are commonly prescribed for women. Methods This was a review of data provided in the product prescribing information for Flibanserin, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, other serotonergic antidepressants, and triptans. Main Outcome Measures The incidence of adverse events was assessed. Results The incidences of hypotension, syncope, and sedation-related adverse events (eg, dizziness, somnolence, fatigue) in studies of Flibanserin were within the ranges observed for serotonergic antidepressants; the rates of these adverse events were generally lower with triptan medications. Other Flibanserin-associated adverse events (eg, nausea, insomnia, dry mouth) occurred more commonly in patients taking antidepressant medications. Conclusion Although medications that affect the serotonin system have varying adverse event profiles (likely mediated by differences in serotonin-related mechanisms of action, specific brain structures affected, and effects on other neurotransmitter systems), the occurrence of central nervous system–related adverse events was not dissimilar between Flibanserin and serotonergic antidepressants. Kingsberg SA, McElroy SL, Clayton AH. Evaluation of Flibanserin Safety: Comparison with Other Serotonergic Medications. Sex Med Rev 2019;7:380–392.
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Flibanserin in postmenopausal women with hypoactive sexual desire disorder results of the plumeria study
The Journal of Sexual Medicine, 2017Co-Authors: David Portman, Louise Brown, James Yuan, Robert Kissling, Sheryl A KingsbergAbstract:Abstract Background Hypoactive sexual desire disorder (HSDD) is a common sexual disorder in younger and older women. Flibanserin is approved for the treatment of acquired generalized HSDD in premenopausal women only. The efficacy of Flibanserin for postmenopausal women with HSDD was demonstrated in the first of two North American randomized, double-blinded, placebo-controlled trials (SNOWDROP). Aim To evaluate the safety and efficacy of Flibanserin in postmenopausal women with HSDD in a second randomized, double-blinded, placebo-controlled trial (PLUMERIA). Methods Naturally postmenopausal women were randomly assigned to receive Flibanserin (100 mg/d) or placebo. Efficacy outcomes were assessed using the last-observation-carried-forward imputation method. Outcomes Safety assessment included incidence of adverse events. Primary efficacy outcomes were the number of satisfying sexual events and the Female Sexual Function Index desire domain (FSFI-d) score. Results The study population (Flibanserin, n = 376; placebo, n = 369) included primarily white women (84.7%), with a mean age of 56.1 years and a mean HSDD duration of 5.0 years. When the study was discontinued early by the sponsor, 45.3% of randomly assigned patients had completed week 16 (which served as the primary analysis time point). The most common adverse events in Flibanserin-treated patients were insomnia (7.7%), somnolence (6.9%), and dizziness (6.4%). Improvement from baseline to week 16 (last-observation-carried-forward) in FSFI-d score was significantly greater for Flibanserin compared with placebo (P = .011); however, the between-group comparison for satisfying sexual events did not reach statistical significance. Clinical Implications Considered with the findings of the previous randomized controlled trial (SNOWDROP), the results of this study support the safety and efficacy of Flibanserin in postmenopausal women. Strengths and Limitations This was a well-designed randomized, placebo-controlled trial. A key limitation was early discontinuation by the study sponsor, which decreased the sample size. In addition, the validity of satisfying sexual events as a primary outcome measurement in HSDD studies has been called into question (but was required by the US Food and Drug Administration as a primary end point in studies of female sexual dysfunction at the time this study was conducted). Conclusion Flibanserin was generally well tolerated in this population of naturally postmenopausal women. Despite the greatly decreased power to detect improvement compared with placebo on the efficacy measurements used, results suggest that Flibanserin could be efficacious in postmenopausal women with HSDD. Portman DJ, Brown L, Yuan J, et al. Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study. J Sex Med 2017;14:834–842.
Noel N Kim - One of the best experts on this subject based on the ideXlab platform.
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pd36 06 two arm prospective open label pilot study of Flibanserin versus Flibanserin and sex therapy in women with hsdd
The Journal of Urology, 2020Co-Authors: S Goldstein, Noel N Kim, Rose Hartzellcushanick, Caroline Cochran, Irwin GoldsteinAbstract:INTRODUCTION AND OBJECTIVE:The most common sexual dysfunction in women is Hypoactive Sexual Desire Disorder (HSDD) with both biologic and psychologic components. Flibanserin was the first FDA-appro...
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evaluation of safety for Flibanserin
Expert Opinion on Drug Safety, 2020Co-Authors: Anita H Clayton, Louise Brown, Noel N KimAbstract:Introduction: Hypoactive sexual desire disorder (HSDD) is the most prevalent sexual dysfunction in women, previously managed with off-label therapies. Indicated for premenopausal women, Flibanserin is the first FDA-approved medication to treat HSDD.Areas covered: This review summarizes Flibanserin's pharmacokinetics, proposed mechanism of action, and safety data in clinical trials with a focus on sedation- and hypotension-related adverse events, and drug interactions with alcohol and antidepressants. Sources included peer-reviewed publications and internal data from the manufacturer.Expert opinion: Flibanserin is a well-tolerated and effective treatment that decreases distress and restores sexual desire to a level that is normative for the individual patient with HSDD. Simplification of a risk mitigation program for Flibanserin in the US is likely to increase the number of prescribing clinicians if accompanied with educational efforts to clarify Flibanserin's risk-benefit profile. As Flibanserin is dosed daily and may be used for a decade or more in the typical premenopausal patient, long-term pharmacovigilance data will be essential. Over time, HSDD will be treated by more nonspecialist health care professionals and Flibanserin will likely become established as a significant treatment option along with other medications approved for this indication in the context of a holistic biopsychosocial treatment paradigm.
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effects of timing of Flibanserin administration relative to alcohol intake in healthy premenopausal women a randomized double blind crossover study
The Journal of Sexual Medicine, 2019Co-Authors: James A Simon, Sheryl A Kingsberg, Noel N Kim, Anita H Clayton, Sharon J Parish, Leah MillheiserAbstract:Abstract Introduction Flibanserin is approved in the United States and Canada for the treatment of acquired, generalized, hypoactive sexual desire disorder in premenopausal women. Sedation-related side effects are among the most prevalent adverse events. Although infrequent, hypotension and syncope remain safety concerns because of possible interaction of Flibanserin with alcohol. Aim To evaluate the impact of the timing of alcohol consumption on Flibanserin safety and tolerability. Methods In this single-center, randomized, double-blind, placebo-controlled, 4-treatment crossover study, 64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years) received once-daily Flibanserin 100 mg or placebo during each of two 10-day treatment periods. Study medication was administered on days 1–3 to achieve steady state. On days 4, 6, 8, and 10, after a standard breakfast, participants consumed 0.4 g/kg ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol) 2 hours before taking study medication. Outcomes The primary endpoint was percentage of participants experiencing syncope or orthostatic hypotension–associated adverse events requiring medical intervention. Secondary endpoints included the incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence). Results 1 participant experienced a primary endpoint event (syncope) during treatment with placebo taken 4 hours after ethanol consumption. Within each ethanol dose–timing treatment, there were no statistically significant differences for Flibanserin compared with placebo. Rates of hypotension were 53.3–66.7% after Flibanserin dosing and 57.4–63.3% after placebo dosing. Rates for orthostatic hypotension were 0.0–5.0% after Flibanserin dosing and 1.7–6.6% after placebo dosing. Clinical Implications Ethanol interaction with Flibanserin was not observed in this study. Strengths & Limitations This study provides information regarding the use of Flibanserin after the consumption of moderate amounts of ethanol (0.4 g/kg). However, daytime administration of Flibanserin is not consistent with the drug’s indicated bedtime dosing. Conclusion Flibanserin, at steady state taken 2, 4, or 6 hours after 0.4 g/kg of ethanol intake did not increase the incidence of hypotension, orthostatic hypotension, or syncope compared with either Flibanserin alone or ethanol alone. Simon JA, Clayton AH, Kingsberg SA, et al. Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. J Sex Med 2019;16:1779–1786.
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weight loss in women taking Flibanserin for hypoactive sexual desire disorder hsdd insights into potential mechanisms
Sexual medicine reviews, 2019Co-Authors: James A Simon, Sheryl A Kingsberg, Irwin Goldstein, Noel N Kim, Brittany Hakim, Leah MillheiserAbstract:Abstract Introduction Flibanserin, a multifunctional serotonin receptor agonist and antagonist, is currently approved in the United States and Canada for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. A post hoc analysis of HSDD clinical trial data found that Flibanserin treatment was associated with statistically significant weight loss relative to placebo, even though study patients were not selected for being overweight/obese and were provided no expectation for weight reduction or interventions intended to promote weight loss. Aim To understand possible mechanisms by which Flibanserin may produce weight loss. Methods A literature review was performed using Medline database for relevant publications on the mechanisms of action by which Flibanserin may provide weight loss and the links between sexual function and weight management. Main Outcome Measures Examination of (i) biopsychosocial factors regulating sexual desire, food intake, and weight regulation; (ii) clinical pharmacology of Flibanserin; (iii) neurobiology of brain reward circuitry; and (iv) identification of possible mechanisms common to Flibanserin and weight loss. Results Based on Flibanserin clinical trial data, there was no consistent correlation between weight loss and improvement in sexual function, as assessed by HSDD outcome measures. Nausea, a common adverse event associated with Flibanserin use, also did not appear to be a contributing factor to weight loss. Hypothetical links between Flibanserin treatment and weight loss include modulation of peripheral 5-HT2A receptors and factors such as improved mood and improved sleep. Conclusion Mechanisms of Flibanserin-induced weight loss have not been well characterized but may involve indirect beneficial effects on peripheral 5-HT2A receptors and central regulation of mood and sleep. Future research may better elucidate the links between sexual function and weight management and the mechanism(s) by which Flibanserin use may result in weight loss. Simon JA, Kingsberg SA, Goldstein I, et al. Weight Loss in Women Taking Flibanserin for Hypoactive Sexual Desire Disorder (HSDD): Insights into Potential Mechanisms. Sex Med Rev 2019;7:575–586.
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safety and tolerability of evening ethanol consumption and bedtime administration of Flibanserin in healthy premenopausal female subjects
Sexual Medicine, 2019Co-Authors: Leah Millheiser, Sheryl A Kingsberg, Noel N Kim, Anita H Clayton, Sharon J Parish, James A SimonAbstract:Abstract Introduction Flibanserin, a treatment for hypoactive sexual desire disorder, carries warnings for increased risk of severe hypotension and syncope when used with alcohol. However, these warnings are not informed by studies that used Flibanserin’s recommended bedtime dosing because previous alcohol studies assessed Flibanserin’s safety during the day. Aim The aim of this study was to assess the effects of ethanol in a real-world context in premenopausal women taking Flibanserin at bedtime. Methods In a randomized, placebo-controlled, double-blind study, 24 healthy premenopausal women (mean age = 34.5 ± 9.9 years; mean body mass index = 25.2 ± 3.4 kg/m2) were dosed with Flibanserin or placebo for 3 days to achieve steady-state plasma levels. In a clinical research unit, subjects (n = 22) were provided 2 units of wine (150 mL/unit; 12% ethanol content) or a nonalcoholic beverage with a standardized 3-course evening meal. Flibanserin 100 mg or placebo was administered at bedtime 2.5 hours after the end of the evening meal. On a separate day, subjects were provided the alternative beverage (± alcohol) with the same evening meal and dosed with the same treatment (Flibanserin or placebo) at bedtime. After a 5-day washout period, subjects crossed over to the other treatment arm and the protocol was repeated. Main Outcome Measure Adverse events (AEs) and vital signs were monitored. Results In the absence of ethanol, headaches and hypotension were the only AEs that occurred in ≥2 subjects after Flibanserin dosing (placebo corrected rates were 17.4% and 8.7%, respectively). After ethanol consumption, the rate of hypotension after Flibanserin dosing was no greater than with Flibanserin or placebo after nonalcoholic beverage consumption. There were no instances of orthostatic hypotension or syncope and no serious AEs or AEs leading to study discontinuation. Conclusion Flibanserin dosed at bedtime after moderate amounts of alcohol with an evening meal was well-tolerated with no evidence of clinically significant hypotension or syncope. Millheiser L, Clayton AH, Parish SJ, et al. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med 2019;7:418–424.
Michael Sand - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of Flibanserin in postmenopausal women with hypoactive sexual desire disorder results of the snowdrop trial
Menopause, 2014Co-Authors: James A Simon, Sheryl A Kingsberg, Miguel Garcia, Brad Shumel, Vladimir Hanes, Michael SandAbstract:AbstractObjectiveThis study aimed to assess the efficacy and safety of Flibanserin, a serotonin receptor 1A agonist/serotonin receptor 2A antagonist, in postmenopausal women with hypoactive sexual desire disorder (HSDD).MethodsNaturally postmenopausal women with HSDD received Flibanserin 100 mg once
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efficacy of Flibanserin in women with hypoactive sexual desire disorder results from the begonia trial
The Journal of Sexual Medicine, 2013Co-Authors: Molly Katz, Lynna Lesko, Leonard R Derogatis, Ronald Ackerman, Parke Hedges, Miguel Garcia, Michael SandAbstract:Abstract Introduction Hypoactive Sexual Desire Disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty. Aim The aim of this study was to assess the efficacy and safety of the 5‐HT 1A agonist/5‐HT 2A antagonist Flibanserin in premenopausal women with HSDD. Methods This was a randomized, placebo‐controlled trial in which premenopausal women with HSDD (mean age: 36.6 years) were treated with Flibanserin 100 mg once daily at bedtime (qhs) (n = 542) or placebo (n = 545) for 24 weeks. Main Outcome Measures Coprimary end points were the change from baseline to study end in Female Sexual Function Index (FSFI) desire domain score and in number of satisfying sexual events (SSE) over 28 days. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale‐Revised (FSDS‐R) total score, and FSDS‐R Item 13 score. Results Compared with placebo, Flibanserin led to increases in mean (standard deviation) SSE of 2.5 (4.6) vs. 1.5 (4.5), mean (standard error [SE]) FSFI desire domain score of 1.0 (0.1) vs. 0.7 (0.1), and mean (SE) FSFI total score of 5.3 (0.3) vs. 3.5 (0.3); and decreases in mean (SE) FSDS‐R Item 13 score of −1.0 (0.1) vs. −0.7 (0.1) and mean (SE) FSDS‐R total score of −9.4 (0.6) vs. −6.1 (0.6); all P ≤ 0.0001. The most frequently reported adverse events in the Flibanserin group were somnolence, dizziness, and nausea, with adverse events leading to discontinuation in 9.6% of women receiving Flibanserin vs. 3.7% on placebo. Conclusion In premenopausal women with HSDD, Flibanserin 100 mg qhs resulted in significant improvements in the number of SSE and sexual desire (FSFI desire domain score) vs. placebo. Flibanserin was associated with significant reductions in distress associated with sexual dysfunction (FSDS‐R total score) and distress associated with low sexual desire (FSDS‐R Item 13) vs. placebo. There were no significant safety concerns associated with the use of Flibanserin for 24 weeks. Katz M, DeRogatis LR, Ackerman R, Hedges P, Lesko L, Garcia M, and Sand M. Efficacy of Flibanserin in women with Hypoactive Sexual Desire Disorder: Results from the BEGONIA trial. J Sex Med 2013;10:1807–1815.
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continued efficacy and safety of Flibanserin in premenopausal women with hypoactive sexual desire disorder hsdd results from a randomized withdrawal trial
The Journal of Sexual Medicine, 2011Co-Authors: Evan R Goldfischer, Toshio Kimura, Molly Katz, Michael Sand, Jeffery Breaux, Joel D Kaufman, William B Smith, R B PykeAbstract:ABSTRACT Introduction 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 over 24 weeks of double‐blind treatment vs. placebo in premenopausal women with HSDD who showed a predefined response after 24 weeks of open‐label treatment with Flibanserin. Methods Women (N = 738) were treated with open‐label, flexible‐dose Flibanserin (50 mg or 100 mg/day) for 24 weeks. At week 24, women who showed a predefined response, measured using an eDiary, were randomized to 24 weeks of continued Flibanserin therapy at optimized dosage (N = 163) or placebo (N = 170). The criteria for entering the double‐blind phase were an increase from baseline to weeks 21–24 of ≥2 satisfying sexual events (SSE) and/or ≥4 “desire days.” A “desire day” was one in which a woman reported more than “no” desire. Main Outcome Measures Coprimary endpoints were change from randomization to study end in SSE and desire score. Secondary measures included change in Female Sexual Function Index (FSFI) total and desire domain scores and Female Sexual Distress Scale‐Revised (FSDS‐R) total and Item 13 scores. Results During the open‐label period, mean SSE and desire score approximately doubled, and FSFI, FSDS‐R total, and Item 13 scores improved. At the end of the double‐blind period, Flibanserin was superior to placebo in change from randomization in SSE, desire score, FSFI desire domain and total scores, and FSDS‐R total and Item 13 scores ( P Conclusion old> At the end of the 24‐week randomized withdrawal phase of a 48‐week trial in premenopausal women with HSDD, Flibanserin was superior to placebo on measures of SSE, sexual desire, overall sexual function, and sexual distress. Flibanserin was well tolerated, and no withdrawal reactions were observed following discontinuation. Goldfischer ER, Breaux J, Katz M, Kaufman J, Smith WB, Kimura T, Sand M, and Pyke R. Continued efficacy and safety of Flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): Results from a randomized withdrawal trial. J Sex Med 2011;8:3160–3170.
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Flibanserin a potential treatment for hypoactive sexual desire disorder in premenopausal women
Women's Health, 2010Co-Authors: Anita H Clayton, Robert Pyke, Lorraine Dennerstein, Michael SandAbstract:Hypoactive Sexual Desire Disorder (HSDD) is defined as a persistent or recurrent deficiency of sexual fantasies and desire for sexual activity, which causes marked personal distress or interpersonal difficulty, and is not better accounted for by another psychiatric disorder or the direct physiological effects of a substance (e.g., a medication) or medical condition. HSDD is believed to be the most common form of Female Sexual Dysfunction and is associated with emotional distress and relationship problems. No pharmacologic therapy is approved for the treatment of HSDD in premenopausal or naturally postmenopausal women. Flibanserin is a 5-HT1A agonist/5-HT2A antagonist that is under investigation as a treatment for HSDD in women. The aim of this article is to present an overview of the pharmacology, clinical efficacy and safety of Flibanserin. Flibanserin is an investigational drug that is not licensed for any indication in any country.