Orexigen enrolls Ph III Contrave trial

Orexigen Therapeutics, a US firm focused on the treatment of central nervous system disorders, including obesity, says it has completed enrollment in NB-303 and NB-304, the final two Phase III clinical trials for Contrave, its lead obesity product candidate, which is a fixed-dose combination of bupropion and naltrexone. This marks the completion of patient enrollment for the full Contrave Phase III program, keeping the drug on track for a New Drug Application submission to the Food and Drug Administration in late 2009. 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 study is being conducted at 36 centers across the USA and has randomized approximately 1,495 patients.