Orexigen Received The FDA's Approval For Contrave Yet Questions Remain

The Story. On September 10, 2014 the United States Food and Drug Administration (FDA) approved Orexigen Therapeutics' (NASDAQ: OREX) weight-management drug, Contrave, as a treatment indication for patients suffering from overweight and obesity. Diagnosed by the body mass index (BMI), a patient who is overweight has the BMI of at least 27 with one or more coexisting disease, including high blood pressure, diabetes Type 2, and high cholesterol. Having the BMI of 30 or greater is clinically diagnostic of obesity. In the United States (US), roughly 75 percent of the population is either overweight or obese. Contrary to a common misconception stating that patients with obesity are lazy to exercise, overweight and obesity are rather due to the increasing cultural and technological advancement, which transform modern day lifestyles toward those that are progressively deskbound.

orexigen_update.pngSource: Orexigen

More Insight. Research shows that obesity increases one's risk of having chronic diseases, including cancer, diabetes, high blood pressure, heart problems, as well as, low self-esteem and subjecting one to be a victim of discriminations. “Obesity continues to be a major public health concern,” said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research. Dr. Guettier continues, “When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition.”

Even More. Contrave is the generic combinations of extended release formulation of naltrexone, commonly used to treat opioid and alcohol addictions, plus another medicine called bupropion. Typically used as a safe and efficacious psychiatric medicine to treat depression and seasonal affective disorder, bupropion also has the therapeutic benefit of helping patients to quit smoking. Bupropion, however, can cause dose dependent seizures. Hence, Contrave is not recommended for patients with a history of seizures. There is also an increased risk of suicidal and psychiatric behaviors associated with bupropion. The Agency, accordingly, placed these precautions on the drug's "boxed warnings." That being said, the FDA requires Orexigen to conduct the following clinical studies after approval to monitor Contrave's safety and efficacy: two heart studies, one to evaluate outcome for risks of heart diseases, and the other to assess signal conductions; two safety and efficacy trials in the pediatrics population, one involves kids in the range, 12 to 17 years of age and the other is for children age 7 to 11 years old; an animal study to assess the drug's effect on learning, memory, focus, and development behavior; and one additional clinical trial to check for Contrave's interactions with other meds. A question one must consider though is why have other FDA-approved weight-management drugs – Belviq of Arena Therapeutics (NASDAQ: ARNA), GlaxoSmithKline's (ADR) (NYSE: GSK) orlistat, and Vivus, Inc.'s (NASDAQ:VVUS) Qsymia – been unable to create traction in sales?

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