Contrave: Additional Phase III data

Additional data from the double-blind, U.S. Phase III COR-I (NB-301) trial were published in the Lancet, including a sensitivity analysis of all patients who completed the full 56 weeks of treatment. The analysis showed that 17% of patients in the high-dose (32 mg naltrexone SR/360 mg bupropion SR) Contrave group (n=296) and 14% in the low-dose (16 mg naltrexone SR/360 mg bupropion SR) group (n=284) achieved >=15% body weight loss vs. 3% of placebo patients (n=290).

A transient increase of about 1.5 mm Hg in mean systolic blood pressure (SBP) was observed in both Contrave groups during the first 8 weeks. Mean SBP returned to baseline after week 12 and decreased by about 1 mm Hg below baseline for the remainder of the study. The placebo group had a 1.5 mm Hg reduction in mean SBP from baseline during the first 12 weeks, after which reductions ranged from 1.5-3 mm Hg below baseline. Treatment with Contrave was not associated with increased depression or suicidality events compared with placebo. ...