Studies: Orexigen's anti-obesity drug shows added benefits Print E-mail
By Staff and Wire Reports   
Sunday, 25 October 2009 08:14

OrexOrexigen® Therapeutics, Inc (Nasdaq: OREX) on Saturday announced new data from trials for Contrave® to expand on top-line results announced in July. Contrave is the first of the Company's two late stage candidates for the treatment of obesity. These data were presented during a panel discussion at the 27th Annual Scientific Meeting of The Obesity Society.

Contrave is a pill that combines the antidepressant Wellbutrin, known generically as bupropion, with a sustained- release version of naltrexone, an opioid blocker used to treat alcoholism and other addictions.

New obesity treatments are needed for what has become a public health epidemic as obesity is a leading cause of diabetes, heart disease and many other serious medical problems, and the condition is rising at alarming rates.

 

These new data show that after completing 56 weeks of therapy with Contrave32:

  • Approximately 34-48% of patients lost at least 10% of their baseline body weight and approximately 17-23% lost at least 15%;
  • Obese patients classified as higher risk for developing cardiovascular disease and diabetes demonstrated significant improvement in markers of cardiometabolic risk such as waist circumference, HDL, and triglycerides;
  • Patients with type 2 diabetes taking Contrave who began the trial with a hemoglobin A1c (HbA1c) level greater than 8% saw a mean HbA1c reduction of 1.1%, which was highly statistically significant compared to placebo;
  • Patients reported an increased ability to control their eating and resist food cravings; and
  • There was no evidence of increased abuse liability.

"These data show that Contrave provides obese patients with meaningful reduction in weight and improvement in important markers of cardiometabolic risk, with even greater improvement seen in patients at higher risk," said Dennis Kim, M.D., Senior Vice President of Medical Affairs. "Results also illustrate the robust glycemic benefit of Contrave in patients who have poorly controlled diabetes, as defined by a hemoglobin A1C level greater than 8.0. These patients experienced a clinically meaningful A1C reduction of 1.1% from baseline."

Those differences are considered robust enough for likely FDA approval and the company said it was on track to apply for U.S. approval in the first half of next year.




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