US Food and Drug Administration Approval of Flibanserin

Woloshin, Steven; Schwartz, Lisa M.

doi:10.1001/jamainternmed.2016.0073

Cited by 25 publications

(14 citation statements)

References 3 publications

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“…In the context of the recent US Food and Drug Administration approval of flibanserin, the first drug to treat low sexual desire in women, 46 these findings are relevant to the current debate about whether striving for a pharmaceutical solution to women’s sexual desire problems is an appropriate and feasible goal. 45 47 Some authors have suggested that women with complaints of low sexual interest might benefit most from integrative approaches that accord with a biopsychosocial model.…”

Section: Discussionmentioning

confidence: 98%

What factors are associated with reporting lacking interest in sex and how do these vary by gender? Findings from the third British national survey of sexual attitudes and lifestyles

et al. 2017

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ObjectivesTo investigate factors associated with reporting lacking interest in sex and how these vary by gender.SettingBritish general population.DesignComplex survey analyses of data collected for a cross-sectional probability sample survey, undertaken 2010–2012, specifically logistic regression to calculate age-adjusted OR (AOR) to identify associated factors.Participants4839 men and 6669 women aged 16–74 years who reported ≥1 sexual partner (opposite-sex or same-sex) in the past year for the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3).Main outcome measureLacking interest in sex for ≥3 months in the past year.ResultsOverall, 15.0% (13.9–16.2) of men and 34.2% (32.8–35.5) of women reported lacking interest in sex. This was associated with age and physical and mental health for both men and women, including self-reported general health and current depression. Lacking interest in sex was more prevalent among men and women reporting sexually transmitted infection diagnoses (ever), non-volitional sex (ever) and holding sexual attitudes related to normative expectations about sex. Some gender similarities in associated relationship and family-related factors were evident, including partner having had sexual difficulties in the last year (men: AOR 1.41 (1.07–1.86); women: AOR 1.60 (1.32–1.94)), not feeling emotionally close to partner during sex (men: 3.74 (1.76–7.93); women: 4.80 (2.99–7.69) and ease of talking about sex (men: 1.53 (1.23–1.90);women: 2.06 (1.77–2.39)). Among women only, lack of interest in sex was higher among those in a relationship of >1 year in duration and those not sharing the same level of interest (4.57 (3.87–5.38)) or preferences (2.91 (2.22–3.83)) with a partner.ConclusionsBoth gender similarities and differences were found in factors associated with lacking interest in sex, with the most marked differences in relation to some relationship variables. Findings highlight the need to assess, and if appropriate, treat lacking interest in sex in a holistic and relationship-specific way.

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Section: Discussionmentioning

confidence: 98%

What factors are associated with reporting lacking interest in sex and how do these vary by gender? Findings from the third British national survey of sexual attitudes and lifestyles

et al. 2017

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“…In some cases, the sponsor’s protocol may have been written without FDA input – or even in contradiction to FDA’s recommendations about design or analysis. (17, 18) Consequently, analyses by FDA staff may deviate from the sponsor’s pre-specified analysis plan if the FDA believes that there is a better way to analyze the data to inform its regulatory decisions. (11)…”

Section: Discussionmentioning

confidence: 99%

ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials

et al. 2016

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Background Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. Purpose To validate results posted on ClinicalTrials.gov against publicly-available FDA reviews on Drugs@FDA. Data sources ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical/statistical reviews). Study selection 100 parallel-group, randomized trials for new drug approvals (1/2013 – 7/2014) with results posted on ClinicalTrials.gov (3/15/2015). Data extraction Two assessors systematically extracted, and another verified, trial design, primary/secondary outcomes, adverse events, and deaths. Results The 100 trials were mostly phase 3 (90%) double-blind (92%), placebo-controlled (73%), representing 32 drugs from 24 companies. Of 137 primary outcomes from ClinicalTrials.gov, 134 (98%) had corresponding data in Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results; most differences were nominal (i.e. relative difference < 10%). Of 100 trials, primary outcome results in 14 could not be validated . Of 1,927 secondary outcomes from ClinicalTrials.gov, 1,061 (55%) definitions could be validated and 367 (19%) had results. Of 96 trials with ≥ 1 serious adverse event in either source, 14 could be compared and 7 were discordant. Of 62 trials with ≥ 1 death in either source, 25 could be compared and 17 were discordant. Limitations Unknown generalizability to uncontrolled or crossover trial results. Conclusion Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half of secondary outcomes could not be validated because Drugs@FDA only includes “key outcomes” for regulatory decision-making; nor could serious adverse events and deaths because Drugs@FDA frequently only includes results aggregated across multiple trials.

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“…Although the phase III studies indeed suggested some effect on sexual desire (DeRogatis et al, 2012; Thorp et al, 2012), it is questionable whether this drug is superior to placebo (Saadat et al, 2017; Anderson and Moffatt, 2018). Perhaps this is related to the fact that flibanserin was approved because of political pressure rather than because of proven efficiency (Woloshin and Schwartz, 2016). Interestingly, the effects of flibanserin on vaginal responses to sexual stimuli has not been evaluated and, as mentioned, its effect on subjective measures, mainly self-reports, of sexual desire is questionable.…”

Section: Sexual Approach Behaviorsmentioning

confidence: 99%

Modeling Human Sexual Motivation in Rodents: Some Caveats

Moëne

Ågmo

2019

Front. Behav. Neurosci.

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Sexual behavior is activated by motivation. An overwhelming majority of experimental studies of the intricacies of sexual motivation has been performed in rodents, most of them in rats. Sometimes it is desirable to generalize results obtained in this species to other species, particularly the human. It is hoped that studies of the neurobiology of rodent sexual behavior may shed light on the central nervous mechanisms operating in the human, and the search for efficient pharmacological treatments of human sexual dysfunctions relies partly on studies performed in rodents. Then the issue of generalizability of the rodent data to the human becomes crucial. We emphasize the importance of distinguishing between copulatory acts, behavior involving the genitals, and the preceding event, the establishment of physical contact with a potential mate. Comparisons between the structure of copulatory behavior in rats and humans show abysmal differences, but there may be some similarity in the underlying mechanisms. The endocrine control of sex behavior is shortly mentioned, and we also compare the effects of the few drugs known to affect both rodent and human copulatory behavior. The stimuli activating sexual motivation, often called desire in the human literature, are examined, and the sexual approach behaviors in rats and humans are compared. There is a striking similarity between these species in how these behaviors respond to drugs. It is then shown that the intensity of sexual approach is unrelated to the intensity of copulatory behavior. Even though the approach is a requisite for copulation, an activity that requires at least two individuals in close physical contact, these two aspects of sexuality do not covary. This is similar to the role of the testosterone in men and male rats: although the hormone is needed for sex behavior, there is no correlation between serum testosterone concentration and the intensity of copulation. It is also pointed out that human sexual behavior is mostly determined by social conventions, whereas this is not the case in rats and other rodents. It is concluded that some observations in rats can be generalized to the human, but extreme caution must be exercised.

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US Food and Drug Administration Approval of Flibanserin

Cited by 25 publications

References 3 publications

What factors are associated with reporting lacking interest in sex and how do these vary by gender? Findings from the third British national survey of sexual attitudes and lifestyles

What factors are associated with reporting lacking interest in sex and how do these vary by gender? Findings from the third British national survey of sexual attitudes and lifestyles

ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials

Modeling Human Sexual Motivation in Rodents: Some Caveats

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