NAPSR News: Takeda and Orexigen Announce FDA Approval of New Weight Loss Drug

WASHINGTON - Sept. 12, 2014 - PRLog -- Takeda Pharmaceuticals and Orexigen® Therapeutics, Inc  have announced the FDA  approval of Contrave®  ®(naltrexone HCI and bupropion HCI) extended release tablets to treat obese or overweight adults  with at least one weight-related comorbid condition.  Contrave®   was evaluated in four 56-week multicenter, double-blind, placebo-controlled obesity trials (CONTRAVE Obesity Research, or  COR-I, COR-II, COR-BMOD, and COR-Diabetes)   involving 4,536 patients.

“Today’s 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,” said Douglas Cole, president, Takeda Pharmaceuticals USA, Inc. “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.” The FDA did provide a stipulation in accordance with the approval of Contrave , Takeda and Orexigen have agreed to multiple post-marketing requirements which includes assessing the safety and efficacy of Contrave® for weight management in obese pediatric patients. A new randomized double-blind, placebo-controlled study will be implemented to assess the effects of long-term treatment with Contrave® on the incidence of major adverse cardiovascular (CV) events in overweight and obese subjects with CV disease or multiple CV risk factors.

The American Medical Association and other medical and government organizations have recognized obesity as a chronic disease. According to the Centers for Disease Control and Preventios more than one-third (34.9% or 78.6 million) of U.S. adults are obese.

Takeda’s portfolio of cardiometabolic products will see a substantial boost with the addition of Contrave®. Industry anaylsts predict US sales of Contrave® to amount to approximately $200 million in 2016.  The commercial launch of Contrave® is expected to happen in the fall of 2014.

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