Orexigen Therapeutics, Inc announced new data from the COR-I, COR-II and COR-Diabetes trials for Contrave (bupropion SR/ naltrexone SR) 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.
"The focus of this panel discussion on pharmacotherapy among distinguished members of the scientific community serves as further validation that medication may play an important role in the treatment of obesity," said Eduardo Dunayevich, chief medical officer, Orexigen Therapeutics. "We believe that, if approved, Contrave can benefit a broad range of obese patients. The results of the COR program, coupled with recently disclosed results from our Empatic Phase 2b trial, support our belief that these two product candidates can help fill the current gap in obesity treatment by providing physicians with multiple pharmacologic options to address the varying needs of this diverse patient population."
All Phase 3 trials in the COR programme were 56 week, randomized, double-blind, placebo-controlled trials. The co-primary endpoints were the proportion of patients achieving at least 5 per cent 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 Contrave with the FDA in the first half of 2010.
Orexigen Therapeutics is a biopharmaceutical company focused on developing therapies that offer multiple approaches to treating obesity.