A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder

Gasior, Maria; Hudson, James I.; Quintero, Javier; Ferreira‐Cornwell, M. Celeste; Radewonuk, Jana; McElroy, Susan L.

doi:10.1097/jcp.0000000000000702

Cited by 46 publications

(46 citation statements)

References 14 publications

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“…Additional long-term data are available from a 12-month extension study to the short-term studies. 75 Of the 604 enrolled participants, 369 completed the study. Discontinuation rate because of an AE was 9.0%.…”

Section: Lisdexamfetaminementioning

confidence: 99%

Binge eating disorder revisited: what’s new, what’s different, what’s next

Citrome

2019

CNS Spectr.

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Binge eating disorder (BED) is the most common type of eating disorder. According to the most recent data available, the estimated lifetime prevalence of BED among US adults in the general population is 0.85% (men 0.42% and women 1.25%). Among psychiatric treatment populations, prevalence is several-fold higher. Although many people with BED are obese (BMI ≥ 30 kg/m2), roughly half are not. In the DSM-5, BED is defined by recurrent episodes of binge eating (eating in a discrete period of time, an amount of food larger than most people would eat in a similar amount of time under similar circumstances and a sense of lack of control over eating during the episode), occurring on average at least once a week for 3 months, and associated with marked distress. BED often goes unrecognized and thus untreated; in one study, 344 of 22,387 (1.5%) survey respondents met DSM-5 criteria for BED, but only 11 out of the 344 had ever been diagnosed with BED by a health-care provider. Psychiatric comorbidities are very common, with most adults with BED also experiencing anxiety disorders, mood disorders, impulse control disorders, or substance use disorders, suggesting that clinicians have patients in their practice with unrecognized BED. Multiple neurobiological explanations have been suggested for BED, including dysregulation in reward center and impulse control circuitry. Additionally, there is interplay between genetic influences and environmental stressors. Psychological treatments such as cognitive behavioral interventions have been recommended as first line and are supported by meta-analytic reviews; however, access to such treatments may be limited because of local availability and/or cost, and these treatments generally lead to little to no weight loss, although successfully eliminating binge eating can protect against future weight gain. Routine medication treatments for anxiety and depression do not necessarily ameliorate the symptoms of BED, but there are approved and emerging medication options, lisdexamfetamine and dasotraline, respectively, that specifically address the core drivers behind binge eating, namely obsessive thoughts and compulsive behaviors regarding food, resulting in marked decreases in binge eating behaviors as well as weight loss.

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Section: Lisdexamfetaminementioning

confidence: 99%

Binge eating disorder revisited: what’s new, what’s different, what’s next

Citrome

2019

CNS Spectr.

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“…The approval of LDX by the FDA in 2015, the same year as BED was acknowledged as an independent diagnosis in the DSM-5 [16], definitely represents a major advance in the psychopharmacological treatment of eating disorders. In a recent safety and tolerability trial, there was a four weeks initial titration dose which started at 30 mg/d LDX; the target and maintenance doses were between 50 and 70 mg LDX given over 48 weeks [151]. This approach is in keeping with the previous literature about LDX in patients with BED [146][147][148].…”

Section: Stimulantsmentioning

confidence: 84%

“…As topiramate [139,140] led to reductions in the number of binge/purge days, in body dissatisfaction and drive for thinness, it seems to be a promising novel development in BN. The approval of LDX for BED after convincing positive RCTs [146][147][148]151] definitely represents a major advance in the psychopharmacological treatment of eating disorders.…”

Section: Psychopharmacological Advances In Edsmentioning

confidence: 99%

Psychopharmacological advances in eating disorders

Himmerich

Treasure

2017

Expert Review of Clinical Pharmacology

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Anorexia nervosa (AN), bulimia nervosa (BN) and binge eating disorder (BED) are the primary eating disorders (EDs). The only psychopharmacological treatment options for EDs with approval in some countries include fluoxetine for BN and lisdexamfetamine for BED. Given the high comorbidity and genetic correlations with other psychiatric disorders, it seems possible that novel medications for these conditions might also be effective in EDs. Areas covered: The current scientific literature has increased our understanding of how medication could be beneficial for patients with EDs on a molecular, functional and behavioral level. On the basis of theoretical considerations about neurotransmitters, hormones and neural circuits, possible drug targets for the treatment of EDs may include signal molecules and receptors of the self-regulatory system such as serotonin, norepinephrine and glutamate, the hedonic system including opioids, cannabinoids and dopamine and the hypothalamic homeostatic system including histamine, ghrelin, leptin, insulin, and glucagon-like peptide-1. Expert commentary: The latest research points to an involvement of both the immune and the metabolic systems in the pathophysiology of EDs and highlights the importance of the microbiome. Therefore, the next few years may unveil drug targets for EDs not just inside and outside of the brain, but possibly even outside of the human body.

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“…Sibutramine reduces binge eating, depressive symptoms, and body weight in obese patients with BED but has been removed from the market for safety reasons [ 16 – 18 ]. Lisdexamfetamine, approved for the treatment of moderate to severe BED in adults [ 19 ], has been shown to reduce binge eating and body weight in patients with BED, but the presence of clinically significant depressive symptoms was a specific exclusionary criterion [ 20 – 22 ]. New treatments for BED, especially for individuals with concomitant MDD and obesity, are greatly needed.…”

Section: Introductionmentioning

confidence: 99%

Concurrent Improvement in Both Binge Eating and Depressive Symptoms with Naltrexone/Bupropion Therapy in Overweight or Obese Subjects with Major Depressive Disorder in an Open-Label, Uncontrolled Study

et al. 2017

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IntroductionBinge eating disorder (BED) is associated with obesity and major depressive disorder (MDD). Naltrexone extended-release (ER)/bupropion ER (NB) is approved as an adjunct to diet and physical activity for chronic weight management. In a prospectively designed 24-week open-label, single-arm, single-site trial of 25 women with MDD and overweight/obesity, NB reduced weight and depressive symptoms.MethodsThis post hoc analysis investigated the relationship between change in self-reported binge eating behavior (evaluated with the Binge Eating Scale [BES]) and changes in weight, control of eating, and depressive symptoms.ResultsAt baseline, 91% of subjects had moderate or severe BES scores, suggesting BED. BES scores were significantly improved from week 4, and by week 24, 83% reported “little or no problem.” Improvement in BES scores correlated with improvement in depressive symptoms and control of eating.ConclusionNB may be effective in reducing binge eating symptoms associated with MDD and overweight/obesity. Evaluation of NB in BED appears warranted.FundingOrexigen Therapeutics, Inc.

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A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder

Abstract: Supplemental digital content is available in the text.

Cited by 46 publications

References 14 publications

Binge eating disorder revisited: what’s new, what’s different, what’s next

Binge eating disorder revisited: what’s new, what’s different, what’s next

Psychopharmacological advances in eating disorders

Concurrent Improvement in Both Binge Eating and Depressive Symptoms with Naltrexone/Bupropion Therapy in Overweight or Obese Subjects with Major Depressive Disorder in an Open-Label, Uncontrolled Study

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