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:4/28/2016)... , April 28, 2016  While Abbott,s ... complement the company,s valve repair and stent business, ... also places Abbott more firmly into patient monitoring.  ... the fastest growing device areas, with double-digit growth ... recent report,  Advanced Remote Patient Monitoring ...
(Date:4/28/2016)... Research and Markets has announced the addition ... report to their offering.      (Logo: ... plastic surgery products market is expected to grow at ... ,The growing adoption of laser in aesthetics is another ... Lasers are used to treat a broad range of ...
(Date:4/28/2016)... April 28, 2016  Marking its one year ... and ovarian cancer risk test, Color Genomics ... genes that highly impact the most common hereditary ... the Color Test analyzes hereditary cancer risks for ... uterine cancers. The Color Test is physician ordered ...
Breaking Medicine Technology:
(Date:4/28/2016)... ... ... Card reminds us that May is National Stroke Awareness Month. According to the Centers ... in the United States; someone has one every 40 seconds. Annually, almost 800,000 strokes ... old. A stroke is when blood flow to the brain is blocked or when ...
(Date:4/28/2016)... ... April 28, 2016 , ... Point ... miniature microphones and headsets announced today that the US Patent Office has approved ... into a structure. This innovative design creates a lightweight and modular audio headset ...
(Date:4/28/2016)... ... April 28, 2016 , ... Accreditation Commission for ... Pharmacy Association (COPA) to develop a comprehensive Specialty Pharmacy Accreditation with Distinction in ... accreditation distinction. ACHC provides a wide range of pharmacy accreditation services that assess ...
(Date:4/28/2016)... ... April 28, 2016 , ... Starting today, households ... mail from USA Medical Prescription Assistance Program. They are customized to reflect the ... package will include a ready-to-use, state-themed card and, in the near future, material ...
(Date:4/28/2016)... (PRWEB) , ... April 28, 2016 , ... For the ... means getting smarter about an important part of overall well-being: mental health. Now, a ... do to promote healthy aging and “cognitive vitality,” which can include everything from honing ...
Breaking Medicine News(10 mins):