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Investigational obesity treatment demonstrated improvements in weight loss, food cravings

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Obese adults taking sustained-release bupropion/naltrexone experienced significant weight loss, improved cardiometabolic risk factors and reduced food cravings, according to phase 3 data from the Contrave Obesity Research program.

The investigational drug (Contrave, Orexigen Therapeutics) combines standard-release bupropion, commonly used to treat depression (Wellbutrin, GlaxoSmithKline) and smoking cessation (Zyban, GlaxoSmithKline), with naltrexone, an opioid antagonist used to treat alcohol and opioid dependence (Revia, Duramed; Vivitrol, Alkermes).

Results of the COR program exceeded FDA benchmarks for clinically significant weight loss, according to an Orexigen Therapeutics statement. The company plans to file for U.S. regulatory approval for Contrave32 (bupropion SR 360 mg/naltrexone SR 32 mg) in the first half of 2010.

All phase 3 trials in the COR program were 56-week, randomized, double-blind, placebo-controlled trials. Participants were randomized to receive twice-daily placebo or varying doses of Contrave with a four-week titration period. The trials also incorporated a typical diet and exercise regimen. The co-primary end points were the proportion of participants achieving at least 5% weight loss and percent change in body weight vs. placebo.

In COR-I (n=1,742), 48% of participants taking bupropion SR 360 mg/naltrexone SR 32 mg lost at least 5% of their body weight after 56 weeks of treatment compared with 16.4% taking placebo. Results were similar in the COR-II program (n=1,496) — 56.3% of participants lost 5% of their body weight vs. 17.1% with placebo. After 56 weeks, mean weight loss was approximately 6% compared with 1% with placebo in both the COR-I and COR-II programs.

Results of the COR-Diabetes trial (n=506) reveal that 44.5% of participants on bupropion SR 360 mg/naltrexone SR 32 mg lost ≥5% of their body weight after 56 weeks — more than double the 18.9% of participants on placebo (P<.001). Patients taking the obesity drug also experienced greater reductions in HbA1c compared with placebo (0.6% vs. 0.1%).

Key secondary endpoints met across the entire COR phase 3 program included significant improvements in cardiovascular and metabolic risk factors, such as HDL, triglycerides, visceral fat and waist circumference.

Additional analyses indicate that participants also experienced reductions in the frequency and strength of food cravings and an increased ability to control their eating compared with placebo.

The drug was generally well tolerated. Nausea was the leading adverse event resulting in discontinuation; however, nausea was mild to moderate, transient and manageable for the majority of patients. Other adverse events included cholecystitis, seizure, palpitations, paresthesia and vertigo.

For more information, visit the Orexigen Therapeutics website.