Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent

2021 ◽  
pp. dtb-2021-000020
Author(s):  
Barbara Mintzes ◽  
Leonore Tiefer ◽  
Lisa Cosgrove
Keyword(s):  
Sexual Desire ◽  
Expert Testimony ◽  
Conflicts Of Interest ◽  
Sexual Experience ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Hypoactive Sexual Desire Disorder ◽  
Low Sexual Desire ◽  
The Us ◽  
Regulatory Decisions

The US Food and Drug Administration (FDA) has approved two drugs for ‘hypoactive sexual desire disorder’ in women, flibanserin (Addyi) in 2015 and bremelanotide (Vyleesi) in 2019. In this paper we examine the outcome measures and clinical trial data upon which regulatory approval was based. In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every two months, bremelanotide to none. Trials for both drugs feature shifts in primary outcomes and a contested indication. A politicised industry-sponsored advocacy campaign and conflicted patient and expert testimony likely influenced flibanserin’s approval at its third attempt. Bremelanotide, with even weaker efficacy, capitalised on the regulatory precedent set by the approval of flibanserin. Reconsideration of regulatory decisions to approve these drugs is in order, as well as a broader examination of how future regulatory decisions can better address conflicts of interest and clinically meaningful benefit.

Pomalidomide

Blood ◽  
2013 ◽  
Vol 122 (14) ◽  
pp. 2305-2309 ◽  
Author(s):  
Martha Q. Lacy ◽  
Arleigh R. McCurdy
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Disease Progression ◽  
Drug Administration ◽  
Second Generation ◽  
Food And Drug Administration ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The Us ◽  
Immunomodulatory Drug

Abstract This spotlight review focuses on the second-generation immunomodulatory drug pomalidomide, which was recently approved by the US Food and Drug Administration. This drug was approved for patients with multiple myeloma who have received at least 2 prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy. This review focuses on the clinical trial data that led to approval and provides advice for treating physicians who are now prescribing this drug for patients.

scholarly journals Pharmacologic Treatment Options for Hypoactive Sexual Desire Disorder

2005 ◽  
Vol 1 (2) ◽  
pp. 263-277 ◽  
Author(s):  
Sheila Y Bolour ◽  
Glenn D Braunstein
Keyword(s):  
Sexual Desire ◽  
Treatment Options ◽  
Sex Therapy ◽  
Pharmacologic Treatment ◽  
Hypoactive Sexual Desire Disorder ◽  
Common Cause ◽  
Low Sexual Desire ◽  
Herbal Therapies ◽  
Phosphodiesterase 5 ◽  
Desire Disorder

Hypoactive sexual desire disorder is the most common cause of sexual dysfunction in women. According to a national survey, approximately a third of all women experience low sexual desire. The etiology of the disorder is often multifactorial. Research in treatment options for hypoactive sexual desire disorder is limited. In this article, treatment options including sex therapy, hormone therapy (estrogen, testosterone, dehydroepiandrosterone, tibolone), non-hormonal medical therapies (buproprion, buspirone, phosphodiesterase-5 inhibitors, amantadine and apomorphine) and herbal therapies (Avlimil®, Arginmax®, Zestra®, yohimbine and Ginkgo biloba) are reviewed.

scholarly journals Socio-demographic Determinants of Low Sexual Desire and Hypoactive Sexual Desire Disorder: A Population-based Study in Iran

2020 ◽  
Author(s):  
Zeinab Hamzehgardeshi ◽  
mina malary ◽  
mahmood moosazadeh ◽  
Soghra Khani ◽  
mehdi Pourasghar ◽  
...  
Keyword(s):  
Sexual Desire ◽  
Sexual Interest ◽  
Population Based ◽  
Reproductive Age ◽  
Hypoactive Sexual Desire Disorder ◽  
Personal Distress ◽  
Women Of Reproductive Age ◽  
Low Sexual Desire ◽  
Confounding Variables ◽  
Socio Demographic Factors

Abstract Background: Various socio-demographic factors have been introduced as the determinants of Low Sexual Desire (LSD), but whether these variables can also contribute to the Hypoactive Sexual Desire Disorder (HSDD), remains uncertain. In this study, we sought to identify the socio-demographic determinants of LSD and HSDD in Iranian women of reproductive age. Methods: This was a population-based, cross-sectional study of 1000 married Iranian women of reproductive age (16-49 years) who met the inclusion criteria. The participants were chosen using the systematic random sampling method from all the healthcare centres in the city of Sari, Iran. LSD was defined as a score no higher than 33 on the Sexual Interest and Desire Inventory-Female (SIDI-F). The sexually-related personal distress was considered as a score of at least 11.0 on the Female Sexual Distress Scale-Revised (FSDS-R), and HSDD was determined based on the sum of those scores. Descriptive statistics were used to describe the socio-demographic characteristics and a chi-square test was run for data analysis using grouping variables. Multivariate logistic regression test was also employed to adjust the effect of confounding variables. Results: The mean score of sexual interest/desire among women was 30.6±10.5. After adjusting the effect of confounding variables, logistic regression showed that socio-demographic variables including age at first intercourse, length of marriage and the level of satisfaction with income were significantly associated with both LSD and HSDD (P<0.01). While advancing age (P<0.001) and body mass index (P<0.01) were just predictors of LSD. Conclusion: Some socio-demographic factors could predict LSD in women, while they were not associated with HSDD. In other words, some factors associated with LSD do not instigate sexually-related personal distress, which is one of the criteria necessary for the diagnosis of HSDD.

scholarly journals Socio-demographic Determinants of Low Sexual Desire and Hypoactive Sexual Desire Disorder: A Population-based Study in Iran

2020 ◽  
Author(s):  
Zeinab Hamzehgardeshi ◽  
Mina Malary ◽  
Mahmood Moosazadeh ◽  
Soghra Khani ◽  
Mehdi Pourasghar
Keyword(s):  
Sexual Desire ◽  
Sexual Interest ◽  
Population Based ◽  
Reproductive Age ◽  
Hypoactive Sexual Desire Disorder ◽  
Personal Distress ◽  
Iranian Women ◽  
Women Of Reproductive Age ◽  
Low Sexual Desire ◽  
Desire Disorder

Abstract Background: Various socio-demographic factors are determinants of Low Sexual Desire (LSD), but whether these are the determinants of Hypoactive Sexual Desire Disorder (HSDD) are unclear. The aim of this study is to evaluate the Socio-demographic determinants of LSD and HSDD in Iranian women of reproductive age.Methods: This was a population-based, cross-sectional study of 1000 Iranian women of reproductive age (15-49 years) who met the inclusion criteria and were chosen through systematic random sampling from all the healthcare centers in Sari, Iran. LSD was defined as a score no higher than 33 on the Sexual Interest and Desire Inventory-Female (SIDI-F); sexually related personal distress was defined as a score of at least 11.0 on the Female Sexual Distress Scale–Revised (FSDS-R); and HSDD was defined as a combination of these scores. Descriptive statistics were used to describe demographic characteristics while for analyzing grouped variables, chi-square test was applied. Multivariate regression test was also used to adjust the effect of confounding variables. Results: The mean score of sexual interest/desire among women who referred to healthcare centers in the city of Sari is estimated as 30.6±10.5. After adjusting the effect of the confounder variables by logistic regression multivariate analysis, the age at first intercourse, the length of time spent in marriage, and the level of satisfaction with income were variables significantly associated with LSD and HSDD (P < .01). Although increasing individual′s age (P < .001) and body mass index (P < .01) were predictors of LSD in women, HSDD was not statistically significant.Conclusion: There are some factors that are associated with LSD in women but are not related to HSDD. In other words, some factors associated with LSD do not cause personal distress which are one of the criteria necessary for HSDD.

scholarly journals Socio-demographic Determinants of Low Sexual Desire and Hypoactive Sexual Desire Disorder: A Population-based Study in Iran

2020 ◽  
Author(s):  
Zeinab Hamzehgardeshi ◽  
mina malary ◽  
mahmood moosazadeh ◽  
Soghra Khani ◽  
mehdi Pourasghar
Keyword(s):  
Sexual Desire ◽  
Sexual Interest ◽  
Population Based ◽  
Reproductive Age ◽  
Hypoactive Sexual Desire Disorder ◽  
Personal Distress ◽  
Women Of Reproductive Age ◽  
Low Sexual Desire ◽  
Confounding Variables ◽  
Socio Demographic Factors

Abstract Background: Various socio-demographic factors have been introduced as determinants of low sexual desire (LSD), but whether these variables can also contribute to hypoactive sexual desire disorder (HSDD) remains uncertain. In this study, we sought to identify the socio-demographic determinants of LSD and HSDD in Iranian women of reproductive age. Methods: This was a population-based, cross-sectional study of 1000 Iranian women of reproductive age (15-49 years) who met the inclusion criteria. The participants were chosen using the systematic random sampling method from all the healthcare centers in Sari, Iran. LSD was defined as a score no higher than 33 on the Sexual Interest and Desire Inventory-Female (SIDI-F), sexually-related personal distress was considered as a score of at least 11.0 on the Female Sexual Distress Scale–Revised (FSDS-R), and HSDD was determined based on the sum of these scores. Descriptive statistics were used to describe the socio-demographic characteristics, while for analyzing grouped variables, Chi-squared test was run. Multivariate logistic regression test was also employed to adjust the effect of confounding variables. Results: The mean score of sexual interest/desire among women was 30.6±10.5. After adjusting for the effect of confounding variables (socio-demographic variables such as age, age at first intercourse, level of education, etc.), logistic regression showed that age at first intercourse, length of marriage, and the level of satisfaction with income were significantly associated with both LSD and HSDD (P<0.01). In addition, advancing age (P<0.001) and body mass index (P<0.01) were predictors of LSD alone. Conclusion: Some socio-demographic factors could predict LSD in women, while they were not associated with HSDD. In other words, some factors associated with LSD do not instigate personal distress, which is one of the criteria necessary for the diagnosis of HSDD.

Toward a Jurisprudence of Drug Regulation

2014 ◽  
Vol 42 (2) ◽  
pp. 244-262 ◽  
Author(s):  
Matthew Herder
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
Phase 1 ◽  
Clinical Trial Data ◽  
The United States ◽  
Trial Data ◽  
Regulatory Decisions ◽  
Clinical Study Reports

Efforts to ensure greater transparency in the regulation of “drugs” (used here as a catch-all for pharmaceuticals, biologics, medical devices, and biomarker-based technologies such as genetic testing paired with a pharmaceutical or biologic) are well underway. For example, laws in the United States and Europe now require registration of most clinical trials beyond phase 1. Yet instances of avoidable harm to patients continue to arise. In response, calls for disclosure of clinical trial data in the form of “clinical study reports,” not just trial designs and basic results, are growing. In this paper, I argue that disclosure of clinical trial data is necessary but insufficient. Rather, the regulatory decisions that flow from those trial data —whether positive (i.e., product approvals) or negative (i.e., abandoned products, product refusals, and withdrawals) —should also be open to outside scrutiny provided they are final in nature.

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