Contrave
Generic name: bupropion and naltrexone
Treatment for: Weight Loss (Obesity/Overweight)
Obesity Society Disappointed by FDA Delay on Approval of Obesity Drug
SILVER SPRING, Md., Feb. 2, 2011 /PRNewswire-USNewswire/ -- In its latest blow to obesity medication development efforts, the US Food and Drug Administration (FDA) yesterday notified Orexigen Therapeutics that it would need to conduct an extremely large-scale study of the long-term cardiovascular effects of its drug, Contrave, before approval could be considered. The economics of such a trial make it extremely unlikely that it can be done; effectively ending hopes for approval, despite the earlier recommendation of the FDA's own advisory panel to approve the drug for use prior to a study.
This makes the third obesity medication that the FDA has disallowed in less than 12 months. The agency has not approved an obesity drug since 1999, and, last year, also removed from the market a drug it approved in 1997. News reports are already speculating that these actions will cause the pharmaceutical industry to avoid the field, stifling research on obesity medications for years to come.
More than a third of US adults are obese, and vulnerable to obesity's damaging consequences. 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.
"In the face of such a devastating, widespread and expensive public health crisis as obesity, it is baffling that the FDA has consistently denied approval for anti-obesity medications," said Dr. Jennifer Lovejoy, President of The Obesity Society (TOS). "The FDA seems to expect that any obesity medication must be as free of side effects as tap water. This is an unrealistic standard and one to which medications for other diseases are not held. TOS will be working with several other professional societies in the coming weeks to meet with FDA and Congressional leaders and discuss improvements to the process of reviewing obesity medications."
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.
SOURCE The Obesity Society
CONTACT: Jane Pratt, Director of Marketing & Communications, The Obesity Society, +1-301-563-6526, jpratt@obesity.org
Web Site: http://www.obesity.org
Posted: February 2011
Related articles
- FDA Approves Contrave (bupropion/naltrexone) for Weight Management - September 10, 2014
- Orexigen Announces June 10, 2014 PDUFA Action Date for Contrave - January 7, 2014
- Orexigen Resubmits Contrave New Drug Application - December 11, 2013
- Orexigen and FDA Identify a Clear and Feasible Path to Approval for Contrave - September 20, 2011
- Obesity Groups See Evidence FDA Decisions Will Discourage Obesity Research - June 23, 2011
- Orexigen Therapeutics Provides a Regulatory Update on Contrave NDA - June 3, 2011
- FDA Issues Complete Response to New Drug Application for Contrave for the Management of Obesity - February 1, 2011
- Orexigen Therapeutics' Investigational Drug Contrave Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity - December 8, 2010
- Orexigen Therapeutics Announces Date of FDA Advisory Committee Review of Contrave for the Treatment of Obesity - June 24, 2010
- Orexigen Therapeutics Announces FDA Acceptance of Contrave New Drug Application for the Treatment of Obesity - June 15, 2010
- Orexigen Therapeutics Submits Contrave New Drug Application to FDA for the Treatment of Obesity - March 31, 2010
Contrave (bupropion and naltrexone) FDA Approval History
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