Orexigen's Phase III obesity drug meets endpoints

San Diego-based Orexigen Therapeutics has announced positive results from the first of four Phase III trials for its obesity drug Contrave. The trial met co-primary and key secondary endpoints. Subjects taking Contrave lost an average of 20.3 pounds to 25 pounds, or 9.3 percent to 11.5 percent of their body weight, while the control group lost just 11 to 16 pounds--5.1 to 7.3 of their weight. Orexigen said the treatment was well-tolerated by patients, and did not cause the depression, suicidality or worsening of mean blood pressure that has felled other experimental weight-loss treatments.

"The results of this trial indicate that additional, clinically significant weight loss can be achieved when Contrave is added to a rigorous program of diet and exercise," said Eduardo Dunayevich, Chief Medical Officer, Orexigen Therapeutics. "We are also very pleased with the safety profile demonstrated by Contrave thus far. We look forward to the results from the remaining Phase 3 trials which will further examine the efficacy, safety and tolerability of Contrave with less intensive behavior modification as well as in patients with Type 2 diabetes patients."

Orexigen announced in early December that it would halt its early-stage work in order to focus developing Contrave.

- here's Orexigen's release [1]

Related Articles:
Orexigen focuses on late stage as CEO resigns [2]
Orexigen's CEO takes leave [3]
Biotechs discuss obesity therapies at BIO [4]
Orexigen claims success in weight-loss trial [5] (July 2007)