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Contrave

Generic name: bupropion and naltrexone
Treatment for: Weight Loss (Obesity/Overweight)

Update: Contrave (bupropion/naltrexone) Now FDA Approved - September 10, 2014

Obesity Groups See Evidence FDA Decisions Will Discourage Obesity Research

WASHINGTON, June 14, 2011 /PRNewswire-USNewswire/ -- The Obesity Care Continuum (OCC), represented by The Obesity Society (TOS), the Obesity Action Coalition (OAC), the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American Dietetic Association (ADA), expresses a deep concern for the recent decision by the FDA, Division of Metabolic and Endocrinologic Products (DMEP), to require Orexigen to conduct a pre-approval cardiovascular outcomes trial for Contrave, even after the FDA Advisory Panel voted for approval of Contrave with a post-approval cardiovascular trial. Furthermore, the OCC believes that the requested pre-approval outcomes trial is unprecedented for any disease and would generate more information than is necessary or feasible.

This verdict has far broader consequences than simply impacting one company and one drug. The decision falls on the heels of two other decisions to disallow additional drugs for obesity treatment made over the last 12 months by the FDA, Center for Drug Evaluation and Research (CDER). The FDA/CDER's charge is "to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States." The agency has not approved an obesity drug since 1999, and, last year, also removed from the market a drug it approved in 1997. The OCC feels this track record shows a trend of the FDA being "benefit-blind" causing an overly risk averse position. "We believe that in order to comprehensively treat the disease of obesity, healthcare professionals must have access to a variety of treatment options. We are extremely disappointed in the short-sightedness of the FDA to objectively and fairly evaluate benefits as well as risks of potential obesity medications," said Jennifer Lovejoy, TOS President.

If the Agency's approach to this class of drugs continues, it will likely further discourage any research and development in the area of obesity ever again. We have already witnessed the withdrawal of the major pharmaceutical companies from this market given the lack of clear predictability surrounding FDA's approval process. We are now seeing the same result in the small biotech market and truly wonder who will fill this void in the absence of any firm drug approval guidance from the FDA.

The greatest consequence however is the impact that lack of treatment options has on the American people. More than a third of US adults are obese, and vulnerable to obesity's damaging consequences and a growing number are severely affected and left without treatment options. Obesity is responsible for the deaths of more than 100,000 Americans each year. Costs attributable to obesity and overweight have been estimated at $270 billion annually, including direct medical costs and indirect costs, such as absenteeism and productivity losses. "The result of limiting treatment options for healthcare professionals will be catastrophic to the health of millions of Americans and our healthcare system," said Joe Nadglowski, OAC President and CEO.

With the obesity epidemic driving risk for type 2 diabetes, sleep apnea, fatty liver disease and many other co-morbidities, we cannot afford to wait any longer to fairly weigh the risks against the benefits and the benefits lost to find a way toward drug approval.

About OCC

All of our organizations work together representing patients, registered dietitians, scientists, clinicians, and surgeons to elevate the recognition of both the prevention and treatment of obesity.

About TOS

The Obesity Society is the leading scientific society dedicated to the study of obesity. Since 1982, The Obesity Society has been committed to encouraging research on the causes and treatment of obesity, and to keeping the medical community and public informed of new advances. Visit TOS at obesity.org.

About OAC

The OAC is a national nonprofit charity dedicated to helping individuals affected by obesity. The OAC was formed to bring together individuals struggling with weight issues and provide educational resources and advocacy tools. In 2011, the OAC launched a national Membership Drive to recruit 50,000 members to strengthen its advocacy efforts and raise awareness of the disease of obesity. For more information on OAC Membership, please visit www.obesityaction.org.

About the ASMBS

The mission of the ASMBS is to advance the art and science of bariatric surgery by continued encouragement of its members to: improve the care and treatment of people with obesity and related diseases; advance the science and understanding of metabolic surgery; foster communication between health professionals on obesity and related conditions; and advocate for health care policy that ensures patient access to high-quality prevention and treatment of obesity. Visit ASMBS at asmbs.org.

About ADA

The American Dietetic Association is the world's largest organization of food and nutrition professionals. ADA is committed to improving the nation's health and advancing the profession of dietetics through research, education and advocacy. Visit ADA at eatright.org.

SOURCE The Obesity Society

CONTACT: Jane Pratt, The Obesity Society, Dir of Mktg & Communications, +1-301-563-6526, jpratt@obesity.org; or James Zervios, Obesity Action Coalition, Director of Communications, (800) 717-3117, jzervios@obesityaction.org

Web Site: http://www.obesityaction.org

Posted: June 2011

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