Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Orexigen Therapeutics has initiated the fourth trial in its Phase III clinical trial program for its lead product candidate Contrave as a treatment for obesity.
Subscribe to our email newsletter
The program includes a set of four trials evaluating a variety of obesity-related outcome measures, which together are expected to support the new drug application for approval of Contrave by the FDA.
This clinical trial 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 trial will take place at approximately 50 centers across the US and is expected to enroll approximately 1,500 individuals.
Gary Tollefson, Orexigen’s president and CEO, said: “Contrave is a unique approach to weight loss that is based on our understanding of the brain as the master regulator of body weight – including appetite, energy expenditure and the reward-based aspects of eating. With this study, Orexigen hopes to provide clinicians and patients with important information on dosing options in the event of a non-response to an initiation dose. This is the final Phase III clinical trial and we are pleased to have initiated each Phase III clinical trial on schedule in support of an NDA submission for Contrave in the second half of 2009.”