Orexigen(R) Therapeutics Announces First of Four Phase 3 Trials of Contrave(R) Meets Co-Primary and Key Secondary...(n Therapeutics. We are also very pleas...)

Date:1/8/2009

n 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."

Patient enrollment has been completed in the three other Phase 3 trials. Orexigen expects to announce top-line results from these trials in mid-2009 and, pending additional positive results, submit a New Drug Application (NDA) with the FDA in late 2009.

Study Details and Results

The objective of this NB-302 trial was to determine the additional weight loss and health benefits of Contrave when added to an intensive diet and exercise program. The trial included the most intensive behavior modification regimen of the Phase 3 program for Contrave, which resulted, as expected, in a high degree of weight loss among placebo patients.

This 56-week, double-blind, placebo-controlled trial conducted at nine U.S. centers evaluated the efficacy and safety of Contrave (32mg naltrexone SR/360mg bupropion SR) compared to placebo in 793 obese patients who participated in an intense behavioral program consisting of counseling, diet and exercise. Patients enrolled in the trial were randomized on a 3 to 1 ratio between Contrave and placebo, and had a body mass index (BMI) of 30 to 45, or as low as 27 in the presence of cardiometabolic co-morbidities. Drug dosages were initially titrated over a four week period and then administered over 52 weeks of therapy at full dose. The co-primary endpoints were percent change in total body weight from baseline and proportion of patients who lost at least 5% of their baseline body weight.

    Efficacy results from this trial are summarized in the following table:

                          Intent-To-Treat*            
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SOURCE  Orexigen Therapeutics, Inc.
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