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DEERFIELD, Ill., and LA JOLLA, Calif. — Takeda Pharmaceuticals USA Inc. and Orexigen Therapeutics Inc. have obtained Food and Drug Administration approval for Contrave extended-release tablets, a medication for chronic weight management.
Takeda and Orexigen said Thursday that Contrave (naltrexone HCI and bupropion HCI) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults who are classified as obese or overweight and have at least one weight-related comorbid condition.
Contrave marks a key addition to Takeda’s portfolio of cardiometabolic products, the company noted. Plans call for Contrave to launch commercially this fall.
"The FDA approval of Contrave is a significant milestone in Takeda’s and Orexigen’s commitment to leading innovation in medicine for patients and physicians dealing with chronic conditions and diseases, such as obesity," Douglas Cole, president of Takeda Pharmaceuticals USA, said in a statement. "It’s important that physicians and appropriate patients have options when discussing weight management, especially when you look at the prevalence of obesity in today’s society. We’re excited about the addition of Contrave to our cardiovascular and metabolic disease portfolio."
"We are extremely proud of our team’s work and commitment to the research and development efforts that have charted our path to Contrave approval," commented Michael Narachi, chief executive officer of Orexigen. "Takeda has been a great, contributing partner throughout this endeavor, and we at Orexigen now look forward to doing everything possible to support them as they bring Contrave to the U.S. market."
Contrave is indicated for people with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight). According to National Health and Nutrition Examination Survey 2012 estimates, about 35% of those age 20 and older were classified as obese based on a BMI of 30 kg/m2 or greater. Obesity has been recognized by the American Medical Association, as well as other medical and government organizations, as a chronic disease.
"Some individuals seeking to manage their weight may require a treatment plan that includes more than lifestyle modification with diet and exercise," stated Dr. Ken Fujioka, director of the Center for Weight Management in the Division of Diabetes and Endocrinology at Scripps Clinic. "Clinical trial data for Contrave demonstrates that this new treatment, when used as an adjunct to a reduced-calorie diet and increased physical activity, is a therapeutic option for some adults who are either overweight with a comorbidity, or obese. In my clinic, I often treat patients who fit these criteria, and now, with the approval of Contrave, I am excited to have a new treatment option to consider for my patients."
