The Contrave clinical development program includes four Phase III clinical trials evaluating a variety of obesity and metabolic-related outcome measures. Orexigen previously announced that enrollment was completed in NB-301 and NB-302.
NB-303 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of Contrave at the expected standard dose with the opportunity for patients to switch to a higher dose if they do not respond after 28 weeks of therapy. This trial is being conducted at 36 centers nationwide and has randomized approximately 1495 patients.
NB-304 is a placebo-controlled, 56-week clinical trial designed to analyze the efficacy, safety and tolerability of Contrave in obese patients with Type II diabetes. This trial is taking place at 51 centers nationwide and has randomized approximately 500 patients.
Contrave is a proprietary fixed dose combination of bupropion sustained release (SR) and the company’s novel formulation of naltrexone SR in a single tablet. Results from the first Phase III clinical trials are anticipated in late 2008 or early 2009.
Gary Tollefson, Orexigen president and CEO, said: “Beyond the standard measures of efficacy, safety and tolerability, we have designed the Contrave Phase III clinical trials to address a number of the key secondary metabolic and behavioral endpoints that complicate are often associated with obesity.”