Fixed-dose, extended-release combination of naltrexone and bupropion reduces craving and body weight: A pooled post hoc analysis.

BACKGROUND: The fixed-dose, extended-release combination of naltrexone and bupropion (NB-ER), approved for obesity treatment, is hypothesized to affect the reward system and reduce food cravings. METHODS: A pooled, on-treatment, post hoc analysis was performed on data from 1967 patients who completed a phase 3 trial of NB-ER (NCT00532779, NCT00567255, NCT00456521, NCT00474630). Changes in weight and cravings based on Control of Eating Questionnaire (CoEQ) and Food Craving Inventory (FCI) scores, as well as mood and craving control, were examined for NB-ER vs placebo at weeks 8, 16, 28, and 56. RESULTS: Patients treated with NB-ER (n = 1206) vs placebo (n = 761) experienced greater weight reductions through 56 weeks (-9.5% ± 8.0% vs -2.7% ± 6.9%). Patients treated with NB-ER vs placebo reported larger improvements in estimated treatment differences (ETDs) for craving control (2.68 [95% CI, 0.85, 4.50]), positive mood (1.35 [95% CI, 0.47, 2.23]), and cravings for savory (-1.81 [95% CI, -3.32, -0.30]) per CoEQ scores. Per FCI scores, patients had improvements in ETDs for cravings for high fats (-0.65 [95% CI, -0.98, -0.32]) and fast-food fats (-0.18 [95% CI, -0.39, -0.03]). Change in body weight at week 56 with NB-ER vs placebo did not differ by baseline CoEQ or FCI scores. CONCLUSIONS: Patients receiving NB-ER experienced greater improvements in cravings, craving control, mood, and weight vs placebo. NB-ER also led to weight reduction in individuals with both low and high baseline cravings. NB-ER is a suitable treatment option for patients with obesity seeking improvements in body weight, mood, cravings, and craving control.