Naltrexone 8mg / Bupropion 90mg modified-release tablets

Background: As the most widespread eating disorder in the world now, binge eating disorder (BED) is a mental condition characterized by recurrent periods of excessive food consumption and an inability to regulate one’s portion sizes. The utilization of a bupropion–naltrexone (NB) combination has been suggested as a potential therapeutic approach for BED. Assessing the effectiveness of NB in the treatment of BED and its accompanying obesity is the purpose of this research. Methods: A comprehensive search was conducted in order to obtain any pertinent articles. PubMed, Scopus, Web of Science, and Cochrane Clinical Trials were consulted against in the databases that were searched. In our final meta-analysis, we incorporated interventional or observational studies that documented the effects of NB therapy for binge eating in adults. We also examined the difference in the mean change between the NB and placebo groups, as well as the disparity in outcomes before and after treatment. Results: This study shows that the use of an NB combination is associated with a statistically significant reduction in the weight, BMI, and Binge Eating Scale (BES) of the patients compared to their weight before treatment with MD: −8.52 (95% CI: −10.01–−6.94, p < 0.00001), MD: −4.95 (95%CI: −9.72–−0.17, p = 0.04), and MD: −7.66 (95%CI: −14.36–0.96, p = 0.02), respectively. The absolute mean change was statistically significantly higher in the drug combination group compared to the placebo group. Conclusions: NB showed efficacy in the improvement of the weight and psychiatric symptoms associated with BED and this provides a promising treatment option.

Abstract licence: CC BY

OBJECTIVE: To compare the efficacy and safety of lisdexamfetamine, topiramate, and naltrexone/bupropion for treating binge eating disorder (BED) using network meta-analysis. METHOD: We systematically searched PubMed, Scopus, ClinicalTrials.gov, and Cochrane Central up to February 2025 for randomized controlled trials evaluating these medications versus placebo in adults with BED. Primary outcomes were changes in binge eating frequency and body weight; secondary outcomes included serious adverse events, discontinuation rates, and common side effects. A frequentist random-effects network meta-analysis was performed. RESULTS: Twelve trials (n = 1988) met inclusion criteria. Both lisdexamfetamine (MD -1.61, 95% CI: -2.41 to -0.81) and topiramate (MD -1.63, 95% CI: -2.53 to -0.74) significantly reduced binge eating frequency versus placebo, with comparable efficacy. Topiramate produced the greatest weight loss (MD -5.5 kg), followed by lisdexamfetamine (-4.6 kg). Naltrexone/bupropion did not significantly reduce binge frequency (MD -2.07, 95% CI: -4.45 to 0.31). Lisdexamfetamine was associated with higher risks of dry mouth and gastrointestinal events. No significant increase in serious adverse events was observed for any medication. CONCLUSIONS: Topiramate and lisdexamfetamine are effective for reducing binge episodes and weight in BED. Naltrexone/bupropion showed modest weight effects but lacked clear efficacy for binge reduction. These findings support topiramate and lisdexamfetamine as primary pharmacologic options for BED.

Abstract licence: CC BY

PURPOSE: Naltrexone-bupropion (Contrave®) has shown efficacy and safety in large randomised controlled trials, predominantly comprising Caucasians. Data are limited in Asian populations. We carried out a retrospective matched cohort study of Chinese patients with obesity to evaluate the efficacy and safety of naltrexone-bupropion in real-world clinical practice. METHODS: We performed a retrospective matched cohort study of Chinese patients with obesity managed in the Obesity Clinic of Queen Mary Hospital in Hong Kong between 1 January 2016 and 31 December 2020. Electronic health records of patients treated with naltrexone-bupropion were retrieved for body weight and height, obesity-related metabolic parameters, and adverse events over a 12-month period. Age- and sex-matched controls from the Obesity Clinic who were only on self-directed lifestyle management were identified for comparison of weight changes. General linear models were used to analyse the change in body weight over 12 months. RESULTS: ), and 37 age- and sex-matched controls were included. Among the 37 naltrexone-bupropion-treated patients, the mean weight loss was 9.2 ± 5.2% at 6 months and 9.7 ± 8.1% at 12 months, which were significantly more than in controls (p < 0.001). Improvements in the obesity-related parameters were observed in association with weight loss over 12 months. Ten patients (27.0%) discontinued naltrexone-bupropion due to side effects, mainly neurological and gastrointestinal manifestations, within the first 12 months. CONCLUSION: We demonstrated real-world efficacy and safety of naltrexone-bupropion among Chinese patients with obesity.

Abstract licence: CC BY

Binge-eating disorder (BED) is a prevalent, refractory, and serious health problem associated with broad morbidities and psychosocial impairments. There is a pressing need to identify effective therapeutics for BED. Naltrexone/bupropion (NB) targets brain reward systems, suggesting that it may be an effective treatment for both obesity and BED. This is the first human laboratory study to examine potential mechanisms underlying NB effects on eating behaviors in those with BED. Fifty participants with BED (72% with obesity) completed a human laboratory study to examine effects of NB on their (1) ability to resist eating preferred high-caloric snack food, (2) calories consumed, and (3) food craving at baseline and following +6 weeks and +12 weeks of NB treatment while enrolled in a 12-week randomized clinical trial (RCT). Hunger, mood, and trough plasma levels of NB were evaluated as secondary outcomes. NB did not influence decisions to eat but did significantly reduce the number of calories consumed, which were negatively associated with 6beta-naltrexol and bupropion levels. NB also reduced craving for preferred high-caloric sweet snacks and reduced hunger ratings at +6 but not +12 weeks. This human laboratory investigation support and extend the findings of the RCT. NB may reduce weight in patients with BED by reducing calories consumed during eating episodes of highly preferred high-caloric food. Further, results identified reduced craving and hunger ratings as potential markers of early treatment response. • There is a pressing need to develop medications for binge eating disorder (BED). • The combination of naltrexone and bupropion (NB) may attenuate food reward. • This human laboratory study found that NB reduced calories consumed, craving, and hunger in those with BED. • Medication levels were associated with reductions in calories consumed. • Craving results were limited to craving for sweet foods.

Abstract licence: CC BY-NC-ND

Summary This study examined the change in weight at 6 months of naltrexone/bupropion (NB), a combination pharmacological therapy for weight management, in real‐world practice in Canada. The study was conducted through an observational, retrospective, single‐arm chart review of adult patients who attended the Wharton Medical Clinic in Ontario, Canada, between 2018 and 2021. The patients had a body mass index ≥30 or ≥27 kg/m 2 with at least one weight‐related comorbidity. They were prescribed NB, titrated from 1 (8 mg/90 mg) to 4 tablets daily, along with lifestyle modification. Approximately 52% of 468 participants completed 6 months of treatment and 48.7% titrated to the maximum dose of 4 tablets daily. Participants were mainly female, with mean age of 49.5 years and BMI 38.4 kg/m 2 . After 6 months, participants lost a mean of 4.23 kg (95% confidence interval [CI] −4.99, −3.47) or 4.05% (CI −4.77, −3.34) of body weight, with 42.5% losing at least 5% of their body weight and 15.5% losing at least 10%. The most frequent adverse events were nausea (5.7%), constipation (5.7%), and headache (2.5%). Participants also experienced decreased appetite (14.7%), decreased cravings (13.9%), decreased hunger (9.4%) and felt full sooner (2.5%), which are changes likely to result in sustained healthy food choices and improved quality of life. The 6‐month NB treatment adjunct to lifestyle modification in a real‐world population resulted in clinically significant weight loss.

Abstract licence: CC BY