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news.Orexigen Therapeutics has completed enrollment in NB-301, the largest of its Phase III clinical trials, for Contrave, its lead obesity product candidate. This represents completion of enrollment in the second of four Phase III trials of Contrave.
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The NB-301 clinical trial is a placebo-controlled, 56-week study intended to analyze the efficacy, safety and tolerability of two doses of Contrave in generally healthy obese patients. This trial is taking place at 34 centers nationwide and has randomized approximately 1742 patients.
Contrave is a proprietary fixed dose combination of bupropion SR and the company’s novel formulation of naltrexone SR in a single tablet. Orexigen chose these two constituent drugs based on preclinical data that suggested that they could both initiate and sustain weight loss.
Gary Tollefson, Orexigen president and CEO, said: “Completion of enrollment in NB-301 is a key step in advancing the Contrave program toward a planned FDA submission in late 2009.”