Orexigen initiates Ph III Conteave study in obesity

San Diego, USA-based Orexigen Therapeutics has initiated the fourth trial in its Phase III clinical trial program for its lead product candidate Contrave (bupropion and naltexone, fixed combination) as a treatment for obesity. The program includes a set of four Phase III trials evaluating a variety of obesity-related outcome measures, which together are expected to support the New Drug Application for review and potential approval of Contrave by the Food and Drug Administration.

This is a 56-week study intended to assess the safety, tolerability and efficacy of Contrave in generally healthy, nondiabetic, obese patients. A unique aspect of this trial design is the blinded re-randomization of any Contrave patients who have not responded at week 28 to receive either a higher dose of Contrave or continue on the patient's original dose, the firm noted.