Orexigen Presents New Data Showing Weight Loss With Contrave

Orexigen has announced a 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.

Reportedly, the 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%.

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%, 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.

Eduardo Dunayevich, chief medical officer of Orexigen Therapeutics, said: “The focus of today’s 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.”

The company said that all phase 3 trials in the Contrave Obesity Research (COR) program were 56 week, randomised, 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 randomised to receive either placebo or Contrave, BID, with a four week titration period.

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, said the company.

Reportedly, the company is on track to submit a New Drug Application (NDA) for Contrave with the FDA in the first half of 2010.