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Orexigen(R) Therapeutics Presents New Data Showing Weight Loss with Contrave Significantly Improves Important Markers of Cardiometabolic Risk
Date:10/24/2009

>Contrave Obesity Research (COR) Trial Design and Safety Profile

All Phase 3 trials in the COR program were 56 week, randomized, double-blind, placebo-controlled trials. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo. Secondary endpoints included multiple markers of cardiometabolic risk, patient reported food cravings and eating control measures, as well as HbA1c in the COR-Diabetes trial. Patients were randomized to receive either placebo or Contrave, BID, with a four week titration period.

As previously reported, seven serious adverse events were attributed by investigators as possibly related to Contrave treatment across the entire COR program. These include cholecystitis (gallbladder inflammation), seizure, palpitations, paresthesia and vertigo. The most frequently observed treatment-emergent adverse events were nausea, constipation and headache. Nausea was the leading adverse event resulting in discontinuation; however, for the majority of patients experiencing nausea, it was mild to moderate, transient and manageable.

At week 56, mean blood pressure was generally unchanged from baseline for Contrave patients compared to placebo patients, who tended to experience a slight decrease (approximately 2 mm Hg) from baseline. Contrave treatment did not appear to disrupt the normal circadian pattern of blood pressure. There was a slight increase in pulse (approximately 1 beat per minute) in Contrave patients compared to placebo patients, whose pulse was generally unchanged. There were no meaningful treatment effects on ECGs or laboratory measures including liver function tests. Treatment with Contrave was not associated with increases in symptoms of depression or suicidal ideation.

The Company is on track to submit a New Drug Application (NDA) for Contr
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SOURCE Orexigen Therapeutics, Inc.
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