Navigation Links
Obesity Society Disappointed by FDA Delay on Approval of Obesity Drug
Date:2/2/2011

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 TOSThe 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.Jane Prattjpratt@obesity.orgDirector of Marketing & Communications301-563-6526
'/>"/>

SOURCE The Obesity Society
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Orexigen® Therapeutics Investigational Drug Contrave® Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity
2. Obesity Organizations Call for a Full and Fair Hearing When the FDA Reviews New Treatments for Obesity
3. Amarin to Present at Canaccord Genuity Cardiovascular, Diabetes & Obesity Conference
4. InfraReDx to Present at Canaccord Genuity 5th Annual Cardiovascular, Diabetes & Obesity Conference
5. HeartWare to Present at the Canaccord Genuity Cardio/Diabetes & Obesity Conference
6. Obesity and Diabetes Are Increasing in Cats
7. American Council on Exercise (ACE) Announces Nationwide Effort to Eliminate Obesity in America
8. Results of Two New Clinical Studies Show Promise of Emerging Mobile Health Technology to Combat Obesity Epidemic
9. A Majority of Surveyed PCPs and Endocrinologists Indicate that they will Prescribe Contrave, Lorqess and Qnexa if these Therapies are Approved for Obesity
10. Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia
11. Arena and Eisai Announce Upcoming Lorcaserin Presentations at Obesity 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)...   Divoti USA will engrave and process ... of the latest FDA requirements, which stipulates new criteria regarding medical ... need of Medical ID jewelry such as Medical ID Bracelets, can ... in terms of the new FDA requirements . ... Divoti offers this dark mark fiber laser ...
(Date:10/11/2017)... 2017  True Health, a leader in integrated ... during National Breast Cancer Awareness month to educate ... Research recently published ... more than 10 million American women are at ... or BRCA2 and have not had testing. These mutations ...
(Date:10/7/2017)... Oct. 6, 2017   Provista, a proven ... $100 billion in purchasing power, today announced a new ... The Newsroom is the online home for ... infographics, expert bios, news releases, slideshows and events. ... a wealth of resources at their fingertips, viewers can ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... The American Board of Family Medicine's (ABFM) Board of ... Executive Officer, succeeding Dr. James C. Puffer upon his retirement. Dr. Newton will serve ... Puffer’s retirement at the end of 2018. Upon assuming the role of President and ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate ... primary prevention of cardiovascular diseases during the 15th Annual Women’s Health Conference. ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a ... has been awarded a contract by the Center for Medicare and Medicaid Services ... accelerate the enterprise use of Agile methodologies in a consistent and high value ...
Breaking Medicine News(10 mins):